Safety
-
Enforcement Report for December 7, 2011
December 7, 2011 11-49
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I
___________________________________
PRODUCT
Round cheese packaged in clear plastic and labeled in part: "DEL BUENO ***Queso Fresco Fresh Cheese CASERO Net Wt. 16 oz (450g)***Keep Refrigerated Ingredients: Pasteurized Milk, Salt, Rennet, and Starter Culture. Recall # F-1890-2011
CODE
"SEP 14 2011"
RECALLING FIRM/MANUFACTURER
Del Bueo, Grandview, WA by telephone and press release beginning September 16, 2011. FDA initiated recall is ongoing.
REASON
Product may be contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
Entire lot, amount unknown
DISTRIBUTION
WA
___________________________________
PRODUCT
a) Limited Edition Organic Grape Tomatoes-10.5 ounce plastic clamshell container, UPC 0 3338365592 5; and b) Fresh and Easy Organic Grape Tomatoes- 7 ounce plastic clamshell container . UPC 20025465. Recall # F-0023-3012
CODE
a) date Sep 01, 2011 through Oct 04, 2011; b)
RECALLING FIRM/MANUFACTURER
Andrew & Williamson Fresh Produce, San Diego, CA, by press release on September 28, 2011 and September 29, 2011. Firm initiated recall is ongoing.
REASON
Tomatoes has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
19,833 lbs / 27,438 cases
DISTRIBUTION
Nationwide and Canada
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PRODUCT
Seasoned Capelin Roes, Masago, 4.4 lb. x4 (ICREST), Item Code: 5600225, INV180410, INV180677. Recall # F-0225-2012
CODE
Lot# 2791,2781
RECALLING FIRM/MANUFACTURER
Icrest International LLC, Carson, CA, by letters on October 21, 2011. Firm initiated recall is ongoing.
REASON
The Icrest Masago fish egg has undeclared wheat.
VOLUME OF PRODUCT IN COMMERCE
68 cases
DISTRIBUTION
Nationwide, Guam, and Costa Rica
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PRODUCT
Private Selection Denali Extreme Moose Tracks Ice Cream, UPC 0 11110 52909 1. Recall # F-0262-2012
CODE
Sell By June 18, 2012 3948 L1
RECALLING FIRM/MANUFACTURER
Recalling Firm: Kroger Co, Cincinnati, OH, by Press Release and email on October 12, 2011.
Manufacturer: Springdale Ice Cream & Beverage, Springdale, OH, Firm initiated recall is ongoing.
REASON
The product may contain undeclared peanut allergen, and, if eaten, could cause a severe allergic reaction to persons sensitive to tree nuts.
VOLUME OF PRODUCT IN COMMERCE
321 cases/6/16 oz paper cartons
DISTRIBUTION
AL, GA, IN, IL, KY, MI, MO, OH, SC, TN, and WV
___________________________________
PRODUCT
Eating Right Soy Protein Burgers 4-count, 10-ounce frozen carton and Eating Right Soy Protein Burgers cases (12 cartons per case). Burger cartons and cases are stamped with the. UPC 79893 80071 and case code date WT11172A. Recall # F-0266-2012
CODE
Best if used before date of November 17, 2012
RECALLING FIRM/MANUFACTURER
Gardenburger, LLC, Clearfield, UT, by press release and letters on October 27, 2011. Firm initiated recall is ongoing.
REASON
Product labeled as Eating Right Soy Protein Burgers but actually containing Eating Right Veggie Burgers, which contain milk, were distributed. Eating Right Veggie Burgers contain milk, an allergen. Milk is not declared in the Soy Protein Burger retail package labeling or the outer cardboard carton labeling.
VOLUME OF PRODUCT IN COMMERCE
168 cases of 12 cartons, each carton containing 4 burgers
DISTRIBUTION
AZ, CA
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PRODUCT
Turkish Pinenut Kernels packed in 10 Kilogram (22.05 lb bulk cases) Cases marked as follows: "PO#50165" "SUZME AKTUNA LTD STI Paxarkuran Mah. Gocmenler Cad. No: 55 Ortaklar-Aydin/Turkiye Ingredients: Pinenuts- Product of Turkiye" Turkish Pinenut Kernels packed in 10 Kilogram (22.05 lb bulk cases) Cases marked as follows: "PO#50558" "SUZME AKTUNA LTD STI Paxarkuran Mah. Gocmenler Cad. No: 55 Ortaklar-Aydin/Turkiye Ingredients: Pinenuts- Product of Turkiye" Turkish Pinenut Kernels packed in 10 Kilogram (22.05 lb bulk cases) Cases marked as follows: "PO#50032" "SUZME AKTUNA LTD STI Paxarkuran Mah. Gocmenler Cad. No: 55 Ortaklar-Aydin/Turkiye Ingredients: Pinenuts- Product of Turkiye" Turkish Pinenut Kernels packed in 10 Kilogram (22.05 lb bulk cases) Cases marked as follows: "PO#49595" "SUZME AKTUNA LTD STI Paxarkuran Mah. Gocmenler Cad. No: 55 Ortaklar-Aydin/Turkiye Ingredients: Pinenuts- Product of Turkiye This product is not labeled. Product is packaged in a sealed plastic bag in an outer cardboard carton. Recall # F-0289-2012
CODE
Lot 27963, PO#50165 Lot 29628, PO#50558 Lot 27427, PO#50032 Lot 27713; PO#49595
RECALLING FIRM/MANUFACTURER
Recalling Firm: Sunrise Commodities Inc., Englewood Cliffs, NJ, by letters on November 3, 2011.
Manufacturer: Aktuna LTD, Aydin, Turkey. FDA initiated recall is ongoing.
REASON
Two lots of Turkish Pinenut Kernels were found to be contaminated with Salmonella through FDA Sampling.
VOLUME OF PRODUCT IN COMMERCE
971 cases (over 21,000 lbs)
DISTRIBUTION
NY, NJ, FL, Canada
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PRODUCT
Fresh Cilantro packaged under Tanimura & Antle label in bunches. Product of the USA. UPC #033383801049. Recall # F-0290-2012
CODE
# 4889
RECALLING FIRM/MANUFACTURER
Sabor Farms LLC, Salinas, CA, by letter on October 28, 2011. North Carolina initiated recall is complete.
REASON
Random sample of Cilantro supplied by Sabor Farms and taken by North Carolina Department of Agriculture was positive for Listeria Monocytogenes .
VOLUME OF PRODUCT IN COMMERCE
11,206 cases
DISTRIBUTION
KY, AR, AZ, TN, NV, SC, WI
___________________________________
PRODUCT
American Egg Products, Pasteurized/Homogenized Frozen Egg Product, Net Weight 5 lbs (2.26 kg). Recall # F-0291-2012
CODE
Lot #272-1
RECALLING FIRM/MANUFACTURER
American Egg Products, Inc., Blackshear, GA, by telephone and fax on October 20, 2011. Firm initiated recall is complete.
REASON
Product was found to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
429 cases
DISTRIBUTION
GA, FA
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II
___________________________________
PRODUCT
1) COTTON CANDY POPCORN: Old violative product label: "***COTTON CANDY ***FLAVORS AVAILABLE: Blue Raspberry, Bubble Gum, Watermelon, Orange Banana*** INGREDIENTS: Sugar, Certified Food Colors (Includes Blue #1 & Red #2), Imitation Flavors.***NET WT. 4 OZ.***" New label: "***COTTON CANDY ***INGREDIENTS: SUGAR, ARTIFICIAL FLAVORS & COLORS, (MAY CONTAIN BLUE #1, RED #3, RED#40, YELLOW #5, YELLOW #6, GREEN #3).***NET WT. 5 OZ.***" Product was packaged in 4 oz poly food bags (20 bags/box). Paradise Gourmet Popcorn flavors: Cotton Candy, 4 oz, Item # 82674 Exp. Date 10/24/2010 to 01/24/2011; Caribbean Caramel Popcorn, 6 oz, Item # 4004262 Exp. 10/24/2010 to 02/24/2011; and Caribbean Caramel Popcorn, 10 oz, Item # 82675 Exp. 10/24/2010 to 02/24/2011.
Recall # F-0014-2012;
2) CARIBBEAN CARAMEL POPCORN: Old violative product label: "***GOURMET POPCORN ***CARIBBEAN CARAMEL***INGREDIENTS: Popcorn, Sugar, Butter, Salt, Water, Lecithin, Corn Syrup, Flavor/Color.***" Product was packaged in 6 oz and 10 oz poly food plastic bags (24 bags/box). New label:"***GOURMET POPCORN Since 1972 ***CARIBBEAN CARAMEL***INGREDIENTS: SUGAR, CORN SYRUP, POPCORN, BUTTER SOYBEAN OIL, LECITHIN, SALT.***NET WT. 10 oz.***" No codes were used on the products. Paradise Gourmet Popcorn flavors: Cotton Candy, 4 oz, Item # 82674 Exp. Date 10/24/2010 to 01/24/2011; Caribbean Caramel Popcorn, 6 oz, Item # 4004262 Exp. 10/24/2010 to 02/24/2011; and Caribbean Caramel Popcorn, 10 oz, Item # 82675 Exp. 10/24/2010 to 02/24/2011. Paradise Direct accounts were notified of the recall on October 25, 2010. Recall # F-0015-2012
CODE
No codes
RECALLING FIRM/MANUFACTURER
Kang Food Service, LLC., Sanford, FL, by telephone on October 25, 2010, FDA initiated recall is ongoing.
REASON
Popcorn was recalled due to inaccurate ingredient statement and lack of food color additives on the product labels.
VOLUME OF PRODUCT IN COMMERCE
1) 681; 2) 635 boxes
DISTRIBUTION
FL
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PRODUCT
1) Kraft Velveeta Shells & Cheese, Original, Single Serve Microwavable Shell Pasta & Cheese Sauce; Net Wt. 2.39 oz. (68g) white plastic cups, 10 cups per case, and 4-2.39 oz (68g) cups Net Wt 9.56 oz. (272g), 6-4 packs per case; UPC 2100002322 - single cup and UPC 2100002339 - 4-pack. Recall:F-0161-2012;
2) Kraft Velveeta Shells & Cheese, Made With 2% Milk Cheese, 1/2 the Fat, Single Serve Microwavable Shell Pasta & Cheese Sauce; Net Wt. 2.39 oz. (68g) white plastic cups, 10 cups per case, and 4-2.39 oz (68g) cups Net Wt 9.56 oz. (272g), 6-4 packs per case; UPC 2100002323 - single cup and UPC 2100002946 - 4-pack. Recall:F-0162-2012;
3) Kraft Velveeta Rotini & Cheese, Broccoli, Single Serve Microwavable Rotini Pasta With Broccoli & Cheese Sauce; Net Wt. 2.44 oz. (69g) white plastic cups, 10 cups per case; UPC 2100002318 - single cup. Recall # F-0163-2012
CODE
1) single cup, Best When Used By 16 MAY 2012; 4-pack, Best When Used By 24 APR 2012, 25 APR 2012, 26 APR 2012, 27 APR 2012, 29 APR 2012, 09 MAY 2012, 10 MAY 2012, 11 MAY 2012, 14 MAY 2012, 15 MAY 2012, 16 MAY 2012;
2) single cup, Best When Used By 25 MAR 2012, 26 MAR 2012, 29 MAR 2012, 30 MAR 2012; 4-pack, Best When Used By 29 MAR 2012, 30 MAR 2012, 12 APR 2012;
3) Best When Used By 29 APR 2012, 30 APR 2012, 03 MAY 2012, 04 APR MAY 2012, 05 MAY 2012, 06 MAY 2012, 13 MAY 2012, 14 MAY 2012
RECALLING FIRM/MANUFACTURER
Recalling Firm: Kraft Foods, Inc., Northfield, IL, by press release on September 30, 2011.
Manufacturers: Kraft Foods Inc., Champaign, IL;
Ryt-Way Industries, Inc., Lakeville, MN. Firm initiated recall is ongoing.
REASON
Possible presence of small, thin wire bristle pieces.
VOLUME OF PRODUCT IN COMMERCE
58,345 single cases and 80,196 4-pack cases
DISTRIBUTION
Nationwide, PR, and Honduras
___________________________________
PRODUCT
1) Peptide Bonded Glutamine, 500 g and 1000 g. Recall # F-0171-2012;
2) CNP Professional ProPeptide MBF, Vanilla, 1 lb, 5 lbs (2270 g), and 10 lb sizes. Recall # F-0172-2012;
3) CNP Professional ProMR Chocolaate, 5 lb and 72 g. Recall # F-0173-2012;
4) CNP Professional ProMR creamy vanilla, 5 lb and 72 g packages. Recall #F-0174-2012;
5) CNP Professional ProPeptide, Creamy Vanilla, 2 lb bottle and 5 lb bag. Recall # F-0175-2012;
6) Kodiak Strength ProPeptide Vanilla Flavor 2 lbs (908 g). Recall # F-0176-2012;
7) Muscle Meals High-Protein Meal Replacement, Dutch Chocolate Smoothie, 2.6 oz (73 g). Recall # F-0177-2012;
8) Muscle Link RecoverX, Creamy Orange 3 lbs 14 oz (1760 g). Recall # F-0178-2012;
9) Muscle Link ProFusion, Creamy Orange 2 lbs (907 g). Recall # F-0179-2012;
10) Healthy Planet Nutrition The Purest Whey Protein, Creamy Vanilla, 21 oz. Recall
F-0180-2012;
11) Bill Pearl's Champion's Choice High Protein Oatmeal 7 lb and 20.5 oz packages. Recall # F-0181-2012;
12) Muscle Meals High Protein Meal Replacement, Creamy Smooth Vanilla, 2.6 oz (73 grams). Recall # F-0182-2012;
13) CNP Professional Pro Dessert Instant Protein Pudding Mix, Vanilla, 39 grams. Recall # F-0183-2012;
14) Muscle Link Pro Fusion, New Chocolate Fudge, 2 lbs. (907 gm). Recall #F-0184-2012;
15) CNP Professional PROGF Pre-Workout Supplement, Lemonade, 1260 grams (2.78 pounds). Recall #F-0185-2012;
16) Muscle Link Pro Fusion, New Tropical Vanilla, 2 lbs. (907 gm, Recall #F-0186-2012;
17) CNP Professional High Performance GF Pre Workout Supplement, Fruit Punch, 1260 gram (2.78 pounds) and 42 gram sizes. Recall # F-0187-2012;
18) CNP Professional ProGF Pre Workout Supplement, Fruit Punch, 2.78 pounds (1260 grams ). Recall #F-0188-2012;
19) CNP Professional High Performance GF Pre Workout Supplement, Grape, 42 grams. Recall # F-0189-2012;
20) CNP Professional Pro-Ms Body Sculpting Protein for Women, Vanilla Caramel, 47 gram package. Recall # F-0190-2012;
21) CNP Professional Pro-Ms Body Sculpting Protein for Women, Swiss Chocolate, 1 lb and 47 gram packages. Recall # F-0191-2012;
22) CNP Professional Pro-Ms Body Sculpting Protein for Women, Wild Berries and Cream, 47 gram packages. Recall # F-0192-2012;
23) Body Tech Pro-Pudding Dutch Chocolate, 1.44 oz. (41 g). Recall # F-0193-2012;
24) Body Tech Pro-Pudding Vanilla Creme, 1.38 oz. (39 g). Recall # F-0194-2012;
25) SMS Size, Mass, Strength, Chocolate, 10 lbs. (4540.2 g). Recall # F-0195-2012;
26) SMS Size, Mass, Strength, Vanilla, 10 lbs. (4540.2 g). Recall # F-0196-2012;
27) S U N Samimi Unique Nutrition, Super Mass Gainer, Vanilla, 5 lb and 12 lb packages. Recall # F-0197-2012;
28) S U N Samimi Unique Nutrition, Super Mass Gainer, Chocolate, 5 lb and 12 lb packages. Recall # F-0198-2012;
29) S U N Samimi Unique Nutrition, Super Mass Gainer, Strawberry, 5 lb and 12 lb packages. Recall # F-0199-2012;
30) Sunplex, S U N Samimi Unique Nutrition, Advanced Protein Meal Replacement, Strawberry, 14-72 g pouches per box (1008 g). Recall # F-0200-2012;
31) Sunplex, S U N Samimi Unique Nutrition, Advanced Protein Meal Replacement, Chocolate Malt, 14-72 g pouches per box (1008 g). Recall # F-0201-2012;
32) CNP Professional ProPeptide, Strawberry, 1 lb, 2 lb bottle and 5 lb bag sizes. Recall # F-0202-2012;
33) CNP Professional ProPeptide, Chocolate, 1 lb, 2 lb bottle and 5 lb bag sizes. Recall # F-0203-2012;
34) CNP Professional ProPeptide, Banana, 1 lb, 2 lb bottle and 5 lb bag sizes. Recall # F-0204-2012;
35) CNP Professional Pro Dessert Instant Protein Pudding Mix, Chocolate, 39 grams. Recall # F-0205-2012;
36) CNP Professional ProPeptide MBF, Strawberry, 1 lb and 10 lb sizes. Recall # F-0206-2012;
37) CNP Professional ProPeptide MBF, Chocolate, 1 lb and 10 lb sizes. Recall # F-0207-2012;
38) CBG 1000. Recall # F-0208-2012;
39) CNP Professional ProGF Pre Workout Supplement, Lemonade, 2.78 pounds (1260 grams ). Recall # F-0209-2012;
40) Progenex Recovery Vanilla, 1 lb and 2.38 lb sizes. Recall # F-0210-2012;
41) Progenex Recovery Chocolate, 1 lb and 2.45 lb sizes. Recall # F-0211-2012;
42) Natura HP Beyond Whey 300 gr bottle. Recall # F-0212-2012;
43) Weider Nutrition Dynamic Muscle Builder Adv, Vanilla, 2 lb. Recall # F-0213-2012;
44) Weider Nutrition Dynamic Muscle Builder Adv, Chocolate, 2 lb. Recall # F-0214-2012;
45) Weider Nutrition Dynamic Muscle Builder Adv, Chocolate, 2 lb. Recall # F-0215-2012
CODE
No code
RECALLING FIRM/MANUFACTURER
Expro Manufacturing Corp., Vernon, CA, by visit beginning September 22, 2011. FDA initiated recall is ongoing.
REASON
Products contain the allergen wheat and does not declare wheat on the product label.
VOLUME OF PRODUCT IN COMMERCE
349,106 units
DISTRIBUTION
AZ, CA, OR, NJ and NM
___________________________________
PRODUCT
1) Seasoned Capelin Roes, Masago 2.2 lbs. x4, Item code: 5600230. Invoice #INV175848, INV176420, and INV 177359. Recall # F-0226-2012;
2) Seasoned Capelin Roes, Masago 4x4.4 lb, Item code: 5600225. Invoice #INV175314, INV174305, INV174904, INV175184, INV176229, INV176360, INV176594, INV177471, INV177704, INV177853, INV179411, INV179665, INV179836, and INV180142. Recall # F-0227-2012
CODE
1) Lot# 1791;
2) Lot # 1381, 1511, 1521, 1591, 1641, 1731, 1801, 1871, 1941, 2011, and 2861
RECALLING FIRM/MANUFACTURER
Icrest International LLC, Carson, CA, by letters on October 21, 2011. Firm initiated recall is ongoing.
REASON
The Icrest Masago fish egg has undeclared wheat.
VOLUME OF PRODUCT IN COMMERCE
1) 60 cases; 2) 945 cases
DISTRIBUTION
Nationwide, Guam, and Costa Rica
__________________________________
PRODUCT
Walkers Nonsuch 1.25Kg Jars Assorted Toffees & Chocolate Éclairs. UPC 7 17227 94054 4. Recall # F-0273-2012
CODE
None
RECALLING FIRM/MANUFACTURER
Walkers' Nonsuch Ltd., Stoke-On-Trent, United Kingdom, by e-mail on October 24, 2011 and by letter on November 11, 2011. FDA initiated recall is ongoing.
REASON
Walker's Nonsuch Assorted Toffees and Chocolate Éclairs may contain undeclared soya lecithin as an allergen.
VOLUME OF PRODUCT IN COMMERCE
60 cartons
DISTRIBUTION
IL
__________________________________
PRODUCT
1) BLUEBERRY PIEROGI Pre-cooked - Just Heat & Serve 16 oz. PACKAGE: in foam trays, sealed with a plastic cover, and placed in a cardboard box (12/case). Recall # F-0274-2012;
2) MEAT (PORK) PIEROGI Pre-cooked - Just Heat & Serve 16 oz. PACKAGE: in foam trays, sealed with a plastic cover, and placed in a cardboard box (12/case). Recall # F-0275-2012;
3) FARMER CHEESE PIEROGI Pre-cooked - Just Heat & Serve 16 oz. PACKAGE: in foam trays, sealed with a plastic cover, and placed in a cardboard box (12/case). Recall # F-0276-2012;
4) STRAWBERRY PIEROGI Pre-cooked - Just Heat & Serve 16 oz. PACKAGE: in foam trays, sealed with a plastic cover, and placed in a cardboard box (12/case). Recall # F-0277-2012;
5) PLUM PIEROGI Pre-cooked - Just Heat & Serve 16 oz. PACKAGE: in foam trays, sealed with a plastic cover, and placed in a cardboard box (12/case). Recall # F-0278-2012;
6) POTATO PIEROGI Pre-cooked - Just Heat & Serve 16 oz. PACKAGE: in foam trays, sealed with a plastic cover, and placed in a cardboard box (12/case). Recall # F-0279-2012;
7) POTATO & CHEESE PIEROGI Pre-cooked - Just Heat & Serve 16 oz. PACKAGE: in foam trays, sealed with a plastic cover, and placed in a cardboard box (12/case). Recall # F-0280-2012;
8) SAUERKRAUT PIEROGI Pre-cooked - Just Heat & Serve 16 oz. PACKAGE: in foam trays, sealed with a plastic cover, and placed in a cardboard box (12/case). Recall # F-0281-2012;
9) SAUERKRAUT & MUSHROOMS PIEROGI Pre-cooked - Just Heat & Serve 16 oz. PACKAGE: in foam trays, sealed with a plastic cover, and placed in a cardboard box (12/case). Recall # F-0282-2012;
10) MUSHROOM PIEROGI Pre-cooked - Just Heat & Serve 16 oz. PACKAGE: in foam trays, sealed with a plastic cover, and placed in a cardboard box (12/case). Recall # F-0283-2012;
11) FARMER CHEESE& POTATO PIEROG Pre-cooked - Just Heat & Serve 16 oz. PACKAGE: in foam trays, sealed with a plastic cover, and placed in a cardboard box (12/case). Recall # F-0284-2012;
12) COTTAGE CHEESE PIEROGI Pre-cooked - Just Heat & Serve 16 oz. PACKAGE: in foam trays, sealed with a plastic cover, and placed in a cardboard box (12/case). Recall # F-0285-2012;
13) SOUR CHERRY PIEROGI Pre-cooked - Just Heat & Serve 16 oz. PACKAGE: in foam trays, sealed with a plastic cover, and placed in a cardboard box (12/case). Recall # F-0286-2012;
14) POTATO & SOUR CREAM & CHIVES PIEROGI Pre-cooked - Just Heat & Serve 16 oz. PACKAGE: in foam trays, sealed with a plastic cover, and placed in a cardboard box (12/case). Recall # F-0287-2012;
15) POTATO with COTTAGE CHEESE & GREEN ONION PIEROGI Pre-cooked - Just Heat & Serve 16 oz. PACKAGE: in foam trays, sealed with a plastic cover, and placed in a cardboard box (12/case). Recall # F-0288-2012;
CODE
All varieties manufactured from July 1, 2011 to October 24,2011. All codes with weeks ending 26-43.
RECALLING FIRM/MANUFACTURER
Polish Harvest Food Products, Inc., Hamtramck, MI, via telephone and letter on October 25, 2011. FDA initiated recall is ongoing.
REASON
During an FDA inspection the firm did not declare FDA&C yellow #6 on all the pierogi finished product labels.
VOLUME OF PRODUCT IN COMMERCE
934 cases of pierogis (12/case)
DISTRIBUTION
IL, IN, MI
___________________________________
PRODUCT
"***Winn Dixie choco charm Vitamin A & D added Chocolate Drink***pasteurized keep refrigerated***ingredients: water, high fructose corn syrup, whey powder (a milk derivative), nondairy creamer (partially hydrogenated soybean oil, corn syrup solids, sodium casenate (a milk derivative), mono and diglycerides, sodium citrate, salt, potassium phosphate, sodium aluminosilicate, carrageenan, artificial flavor), cocoa, salt, guar gum, corn starch, xanthan gum, natural and artificial flavors, carrageenan, monoglycerides, sodium stearoyl lactylate, vitamin a palmitate, vitamin D3***1 Gal***(3.78 L)***O 21140 29830 0***" Container description: Opaque polyethylene gallon jug with handle, with yellow polyethylene cap. Recall # F-0359-2012
CODE
All Lots All Codes
RECALLING FIRM/MANUFACTURER
Recalling Firm: Winn Dixie Stores, Inc., Jacksonville, FL, by press release and by e-mail on August 16, 2011.
Manufacturers: Sunshine State Dairy Farms, LLC, Plant City, FL;
Sunshine State Dairy Farms, LLC, Hammond, LA. Firm initiated recall is ongoing.
REASON
The ingredient label did not declare wheat.
VOLUME OF PRODUCT IN COMMERCE
599 cases
DISTRIBUTION
FL, GA, AL, LA, and MS
___________________________________
PRODUCT
1) Caesar Romaine. 10 oz. plastic bag. Under the following brand names: Ready Pac, Raley's, Safeway. Product labeling reads in part: "Ready Pack: ***Caesar Romaine Crisp Romaine Lettuce Net Wt 10 oz (284g)***". For Ready Pac brand: UPC # 0-7745-00202-6. For Raley's brand: UPC 0-4567-71612-8. For Safeway Farms: UPC 0-21130-98350-6. Recall # F-0363-2012;
2) Ready Pac Santa Fe Caesar Complete Salad, 9.25oz. plastic bag. Product labeling reads in part: "Ready Pac:***Santa Fe Caesar***Romaine, Santa Fe Caesar Salad Dressing, Corn Tortilla Chips and Southwestern Cheese Blend***Net Wt 9.25 oz (262)g: Salad 6 oz Cheese .75 oz(21g) Corn Chips .5 oz (14g)***". UPC # 0-77745-21404-7. Recall # F-0364-2012;
3) Ready Pac Classic Caesar Complete Salad, 10 oz. plastic bag. Product labeling reads in part: "Ready Pac: ***Classic Caesar***Romaine, Caesar Salad Dressing, Cheese & garlic Croutons and Parmesan Cheese***Complete salad*** Total Net Wt: 10 oz (239g). UPC # 0-77745-20566-3. Recall # F-0365-2012;
4) Ready Pac Bella Romaine, 10 oz. plastic bag. Product labeling reads in part: "Ready Pac:*** Bella Romaine Hearts of Romaine Lettuce Net Wt 10 oz (284g)***". UPC # 0-77745-21407-8. Recall # F-0366-2012;
5) Dining In brand (owned by Ready Pac), Classic Caesar Salad Kit, 10 oz. plastic bag. Product labeling reads in part: "Dining In Classic Caesar Salad Kit romaine, Caesar Salad Dressing, Garlic Butter Croutons & Shredded Parmesan Cheese***Salas & Toppings Net Wt: 7.75 oz (220g)". UPC # 0-11225-02530-3. Recall # F-0367-2012;
6) Trader Joe's Romaine Salad 10 oz. plastic bag. Product labeling reads in part: "Trader Joe's Romaine Salad Chopped Romaine Lettuce: ***net wt. 10 oz (283G)***". UPC # 0013-2145. Recall # F-0368-2012;
7) Trader Joe's Very American Salad, 16 oz. plastic bag. Product labeling reads in part: "Trader Joe's Very American Salad iceberg, romaine & red cabbage:***Net Wt. 16 oz (1 lb) 454g***". UPC # 0020-7225. Recall # F-0369-2012
8) Safeway Farms Hearts of Romaine 9 oz. plastic bag. Product labeling reads in part: "Safeway farms Hearts of Romaine European-style crisp romaine lettuce***Net Wt 9 oz (255g)***UPC # 0-21130-98358-2. Recall # F-0370-2012;
9) Safeway Farms Complete Caesar Supreme 10 oz. plastic bag. Product labeling reads in part: "Safeway farms Complete Supreme Caesar***Total Net Wt 10 oz (283g)". UPC # 0-21130-33677-7. Recall # F-0371-2012;
10) Safeway Farms Complete Southwestern Ranch 10.25 oz. plastic bag. Product labeling reads in part: "Safeway farms Complete Southwestern Ranch***Total Net Wt 10.25 (291 g),” UPC # 0-21130-33679-1. Recall # F-0372-2012
CODE
BEST BEFORE NOV 18
RECALLING FIRM/MANUFACTURER
Ready Pac Foods Inc., Irwindale, CA, by press release on November 16, 2011, and on November 17, 2011. FDA initiated recall is ongoing.
REASON
The product may be contaminated with E. coli O157:H7.
VOLUME OF PRODUCT IN COMMERCE
5,379 cases
DISTRIBUTION
CA, AK, MT, NB, NV, NM, SD, WY
___________________________________
PRODUCT
1) Hawaii Candy Fortune Cookies, Net wt 3 oz, (85 g); UPC 073366-12950. Recall # F-0355-2012;
2) Hawaii Candy Petite Wafer cookies, Net wt 3 oz (85 g); UPC 073366-12952. Recall # F-0356-2012;
3) Hawaii Candy Sesame Wafer Cookies, Net wt 3 oz (85 g): UPC 073366-12954. Recall # F-0357-2012;
4) Hawaii Candy Ginger Wafer Cookies, Net wt 3 oz (85 g): UPC 073366-12955. Recall # F-0358-2012
CODE
Codes: 12061, 12062, 12063 and 12064
RECALLING FIRM/MANUFACTURER
Hawaii Candy Inc., Honolulu, HI, by press release and telephone on October 28, 2011. FDA initiated recall is ongoing.
REASON
FDA inspection found four products that contain yellow # 6 as an ingredient but do not include it in the ingredient statement.
VOLUME OF PRODUCT IN COMMERCE
2308 pounds
DISTRIBUTION
HI
The FDA begins a pilot program seeking to expedite notifications of human drug product recalls to the public. The agency will modify the drug product section of the Enforcement Report17, published every Wednesday, to include actions that have been determined to be recalls, but that remain in the process of being classified as a Class I, II, or III action. Such recalls will be listed under the heading, “Recalls Pending Classification: DRUGS.” They will be reposted with their classification once that determination has been made. Send comments or suggestions to CDERRecallPilot@fda.hhs.gov.
RECALLS PENDING CLASSIFICATION: DRUGS
No Recalls Pending Classification this week.
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS I
___________________________________
PRODUCT
CELERITE Slimming Tea, 25 tea bags (2 g each) in box; Made in China. Recall # D-713-2012
CODE
All lots sold by this firm in the past 12 months.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Shaping Beauty, Inc., Huntingdon Valley, PA, via email on March 17, 2011, and press release on March 24, 2011.
Manufacturer: H & S GMP Factory, Kunming, China. FDA initiated recall is ongoing.
REASON
Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared sibutramine.
VOLUME OF PRODUCT IN COMMERCE
257 boxes of 25 tea bags each
DISTRIBUTION
Nationwide
__________________________________
PRODUCT
Avastin 2.5 mg/0.1 mL, packaged in a 1 mL Syringe, Rx Only. Recall # D-826-2012
CODE
All Lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Walgreens Co., Miami, FL, by letters on July 11, 2011 and on July 15, 2011.
Manufacturer: Infupharma LLC, Hollywood, FL. Firm initiated recall is ongoing.
REASON
Non-Sterility: Product found to be contaminated with Streptococcus oralis. The recall was initiated after the firm received reports of infections of endophthalmitis in patients after receiving intravitreal injections of Avastin.
VOLUME OF PRODUCT IN COMMERCE
210 syringes
DISTRIBUTION
FL
___________________________________
PRODUCT
Phenobarbital Tablets, USP, 32.4 mg (1/2 gr), CIV, 1000 count bottles, Rx only, NDC 0603-5166-32. Recall # D-886-2012
CODE
Lot numbers: T150G10B, Exp 08/13; T120J10E, Exp 10/13; and T023M10A, Exp 12/13
RECALLING FIRM/MANUFACTURER
Vintage Pharmaceuticals LLC dba Qualitest Pharmaceuticals, Huntsville, AL, by press release on February 5, 2011 and letter on February 9, 2011. Firm initiated recall is complete.
REASON
Labeling: Label Mix-Up: Hydrocodone Bitartrate/Acetaminophen, 10/500 mg may be mislabeled as Phenobarbital, 32.4 mg
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Nationwide
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II
___________________________________
PRODUCT
Sensorcaine - MPF (Bupivacaine Hydrochloride and Epinephrine Injection, USP) 0.25% with Epinephrine 1:200,000 (as bitartrate); 25 Single Dose Vials, 10 mL; Rx Only; NDC 63323-468-17. Recall # D-813-2012
CODE
Lot number 6101376, Exp 07/12
RECALLING FIRM/MANUFACTURER
Recalling Firm: APP Pharmaceuticals LLC, Schaumburg, IL, by letters dated October 12, 2011.
Manufacturer: APP Pharmaceuticals, LLC, Melrose Park, IL. Firm initiated recall is ongoing.
REASON
Subpotent (Multiple Ingredient Drug): Out of specification for epinephrine assay results at the eight month time point.
VOLUME OF PRODUCT IN COMMERCE
69,000 vials
DISTRIBUTION
Nationwide
__________________________________
PRODUCT
1) Midazolam Injection, USP, 5 mg/mL, CIV, Rx Only, iSecure Syringe, 1 mL Single-dose Sterile Cartridge Unit with Luer Lock, for Intramuscular or Intravenous Use, Preservative-Free, NDC 0409-2307-21. Recall # D-818-2012;
2) Heparin Sodium Injection, USP, 5,000 USP heparin units/0.5 mL, For IV or SC use, Rx Only, iSecure Syringe, 0.5 mL Single-dose Sterile Cartridge Unit with Luer Lock, NDC 0409-1316-25. Recall # D-819-2012;
3) Ketorolac Tromethamine Injection, USP, 30 mg/1 mL, For I.V./I.M. Use, Rx Only, iSecure Syringe, 1 mL Single Use Sterile Cartridge Unit with Luer Lock, NDC 0409-2287-21. Recall # D-820-2012;
4) Ondansetron Injection, USP, 4 mg/2 mL, (2 mg/ mL) For I.M. or I.V. Use, Rx Only, iSecure Syringe, 2 mL Single-dose Sterile Cartridge Unit with Luer Lock, NDC 0409-1120-62. Recall # D-821-2012;
5) Diazepam Injection, USP, 10 mg/2 mL, (5mg/mL), CIV, for I.V. and I.M. use, Rx Only, iSecure Syringe, 2mL Single-dose Sterile Cartridge Unit with Luer Lock, NDC 0409-1273-05. Recall # D-822-2012;
6) Ketorolac Tromethamine Injection, USP, 60 mg/2 mL (30 mg/mL) For I.M. Use Only, Rx Only, iSecure Syringe, 2 mL Single-dose Sterile Cartridge Unit with Luer Lock, NDC 0409-2287-22. Recall # D-823-2012;
7) Midazolam Injection, USP, 2 mg/2 mL, CIV, For Intramuscular or Intravenous Use, Preservative-Free, Rx Only, iSecure Syringe, 2 mL Single-dose Sterile Cartridge Unit with Luer Lock, NDC 0409-2306-22. Recall # D-824-2012
CODE
1) Lot 80680LL, Exp. 08/2011; 90735LL, Exp. 06/2012;
2) Lot #s: 88650LL, Exp 10/11; 89695LL, Exp. 11/2011; 90580LL, Exp. 12/11, 91540LL, Exp. 01/2012; 92540LL, Exp. 02/2012; 93575LL, Exp. 03/12; 94775LL, Exp. 04/12; 96545LL, Exp. 06/2012; 01595LL, Exp. 07/2012; 04750LL, Exp 10/12;
3) Lot #s: 90720LL, Exp. 12/2011; 94655LL, Exp. 04/2012;
4) Lot #s: 79610LL, Exp. 07/2011; 82610LL, Exp. 10/2011; 84515LL, Exp.12/2011; 86665LL, Exp. 02/2012; 88585LL, Exp. 04/2012; 94795LL, Exp. 10/2012; 95640LL, Exp. 11/2012; 01695LL, Exp. 01/2013; 03820LL, Exp. 03/2013;
5) Lot #: 90575LL, Exp. 12/2011;
6) Lot #: 88690LL, Exp. 10/2011;
7) Lot #: 85610LL, Exp. 01/2012
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hospira Inc., Lake Forest, IL, by letters dated July 8, 2011.
Manufacturer: Hospira Inc., Mcpherson, KS. Firm initiated recall is ongoing.
REASON
Lack of Assurance of Sterility: Cracks/breaks were found in the glass cartridges. The cracks may result in leakage of the product with a possibility of contamination and glass particles.
VOLUME OF PRODUCT IN COMMERCE
4,039,570 syringes
DISTRIBUTION
Nationwide and PR
__________________________________
PRODUCT
Vitamin D, (Ergocalciferol Capsules, USP) 1.25 mg (50,000 USP Units)) , Rx ONLY, a)100 count bottles NDC 0574-0194-01, b) 50 count bottle, NDC 0574-0194-50. Recall # D-825-2012
CODE
a) Lot 7209090 7209091 7209092P1 7212088 7212089 7212122 7212782 7212783 7212784 7212793 7212794 7212885 7212886 7213737 7213739; b) Lot 7209092 7212121 7212122S
RECALLING FIRM/MANUFACTURER
Recalling Firm: Paddock Laboratories, Inc., Minneapolis, MN, by letters dated September 6, 2011.
Manufacturer: Strides Arcolab Ltd., Bangalore, India. Firm initiated recall is ongoing.
REASON
Presence of Foreign Substance(s): Paddock Laboratories is recalling Vitamin D - Ergocalciferol Capsules, USP 1.25 mg (50,000 IU) 50 & 100 count capsules because it may contain extraneous foreign matter (glass chip) in product container.
VOLUME OF PRODUCT IN COMMERCE
131,797 bottles
DISTRIBUTION
Nationwide and PR
___________________________________
PRODUCT
1) Bausch & Lomb Soothe XP Emollient (Lubricant), Eye Drops, Sterile 0.5 fl oz (15mL), NDC 24208490. Recall # D-855-2012;
2) Bausch & Lomb Soothe XP Emollient (Lubricant), Eye Drops, Sterile 0.08 fl oz (2.5mL), PROFESSIONAL SAMPLE-NOT FOR SALE. Recall # D-856-2012
CODE
1) Lot #'s: 130241 130541 130831 130841 131381 131391 132081 397291 397381 397561 397711 397731 397921 397931 407051 407611 407631 417061 427131 437271 437501 437521 447181 447191 448061 448071 457001 457171 457191 457881 458001 467201 477101 477111 477911 487311 487571 497111 497561 507741 507861 517131 517911 518021 537001 537131 537141 537391 537661 537671 537921 538051 547011 547201 547221 547231 547631 547651 548171 557021 557032 557451;
2) Lot #'s: 487531 497311 497321 507311 507531 507541 517971 517981 537101 537331 537651 547241 557351 557462 131341 132251 133341 133821
RECALLING FIRM/MANUFACTURER
Bausch & Lomb, Inc., Tampa, FL, by press release and letters on February 24, 2011. Firm initiated recall is ongoing.
REASON
Lack of Assurance of Sterility: Bausch & Lomb initiated a recall of Soothe Xtra Protection (XP) eye drops due to testing which showed specific lots of the product were trending out of specification for preservative efficacy prior to their listed date of shelf-life. Soothe Xtra Protection (XP) may not provide sufficient protection against inadvertent microbial contamination during storage and usage of the product.
VOLUME OF PRODUCT IN COMMERCE
2,772,336 (2.5 mL) & 1,731,225 (15 mL) bottles
DISTRIBUTION
Nationwide, PR, Bermuda, Kuwait, Trinidad, Tobago
___________________________________
PRODUCT
Triamterene and Hydrochlorothiazide Capsules, USP, 50mg/25mg, Rx Only, a) 30-count bottles, NDC #: 54868-0932-01, b) 60-count bottles, NDC #: 54868-0932-06, c) 100-count bottles, NDC #: 54868-0932-04. Recall # D-857-2012
CODE
Lot #: a) 4MLB, 4VQZ, 4VWN, Exp. 01/11; 4HDM, Exp. 05/11; 6980, Exp. 06/11; 4I3M, Exp 06/11; b) 4M7D, Exp. 08/11; c) 4EAX, 4H0E, Exp 06/11; 4QTJ, Exp. 10/11; 4VH2, Exp.12/11; 52AF, Exp. 02/12.
RECALLING FIRM/MANUFACTURER
Physicians Total Care, Inc., Tulsa, OK, by fax on February 21, 2011. Firm initiated recall is complete.
REASON
cGMP Deviations: Product recalled due to slow dissolution attributed to cGMP deviations.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
SeroQUEL quetiapine fumarate 300 mg tablets, 60 tablets, Rx only, NDC 0310-0274-60.
Recall # D-860-2012
CODE
Lot number YB0130, exp 1/9/2014
RECALLING FIRM/MANUFACTURER
Recalling Firm: Astra Zeneca LP, Wilmington, DE, by letter on November 14, 2011.
Manufacturer:AstraZeneca Pharmaceuticals, LP, Newark, DE. Firm initiated recall is ongoing.
Manufacturer:AstraZeneca Pharmaceuticals, LP, Newark, DE. Firm initiated recall is ongoing.
REASON
Presence of Foreign Substance(s): Recalled due to the potential presence of inert polyvinylchloride (PVC) material in the product.
VOLUME OF PRODUCT IN COMMERCE
16,680 units
DISTRIBUTION
Nationwide and PR
__________________________________
PRODUCT
Promethazine Hydrochloride Injection, USP, 50 mg/mL, 25 x 1mL Single Dose Ampuls per Carton, For Deep Intramuscular Use Only, Rx Only, NDC 39822-5500-5 (Ampule), 39822-5500-6 (Carton). Recall # D-866-2012
CODE
Lot #: 113140.1, Exp. 04/2013
RECALLING FIRM/MANUFACTURER
Recalling Firm: X-gen Pharmaceuticals Inc., Horseheads, NY, by letters on October 31, 2011 followed up by telephone and e-mail.
Manufacturer: Hikma Farmaceutica, (Portugal) S.A., Fervenca, Terrugen, Portugal. Firm initiated recall is ongoing.
REASON
Labeling: Label Error on Declared Strength; One side of the carton of the 50 mg/mL Promethazine HCl product is mis-labeled as 25 mg/mL. The front and back panels prominently and correctly states the concentration as 50 mg/mL. One side panel states "Each mL contains 25 mg of promethazine HCl" The product concentration is correct on the ampule label, the package insert and all panels except on one side of the carton.
VOLUME OF PRODUCT IN COMMERCE
1726 cartons
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Enoxaparin Sodium Injection, USP, 100mg/mL, Single Dose Syringes with Automatic Safety Device, For Subcutaneous Injection, Rx Only, Ten 1 mL Syringes per Carton (NDC Carton 0781-3500-69, NDC Syringe 0781-3500-05). Recall # D-868-2012;
2) Enoxaparin Sodium Injection, USP, 150mg/mL, Single Dose Syringes with Automatic Safety Device, For Subcutaneous Injection, Rx Only, Ten 1 mL Syringes per Carton (NDC carton 0781-3655-69 , NDC Syringe 0781-3655-05). Recall # D-869-2012
CODE
1) Lot #: 918004, Exp 08/2013;
2) Lot #: 918008, Exp 08/2013
RECALLING FIRM/MANUFACTURER
Recalling Firm: Sandoz, Inc, Princeton , NJ, by letter on November 17, 2011,
Manufacturer: Baxter Pharmaceuticals Solutions, LLC, Bloomington, IN. Firm initiated recall is ongoing.
REASON
Lack of Assurance of Sterility: Needle of packaged pre-filled syringes may be protruding through the needle guard.
VOLUME OF PRODUCT IN COMMERCE
4,397 Cartons
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Leflunomide Tablets, 10 mg, Rx Only, 30-count Bottle, NDC 0093-0173-56. Recall # D-872-2012
CODE
Lot # 30209292A, Exp 11/2011
RECALLING FIRM/MANUFACTURER
Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letter on October 31, 2011. Firm initiated recall is ongoing.
REASON
Impurities/Degradation Products: One lot of this product does not meet impurity specifications.
VOLUME OF PRODUCT IN COMMERCE
32,325 Bottles
DISTRIBUTION
Nationwide and PR
___________________________________
PRODUCT
1) Children's PANADOL Liquid (Acetaminophen), 80 mg, fl. oz., 2 fl. oz. and 4 fl. oz bottles, UPC: 3-112843-21493-4; UPC: 3-12843-21494-1. Recall # D-876-2012;
2) Children's PANADOL Chewable Tablets, (Acetaminophen), 80 mg, 32 ct tablets,
UPC: 3-09711-03140-3. Recall # D-877-2012;
3) Infant's PANADOL (Acetaminophen) Drops, 80 mg per 0.8 mL dropper, fl. oz. bottles, UPC: 3-12843-21496-5. Recall # D-878-2012;
4) PANADOL Cold & Flu, (Acetaminophen 500mg, Chlorpheniramine Maleate 2mg and Phenylephrine HCl 5mg), 16 Caplets and 2 pouch x 50 packets/carton, UPC 3-09711-05005-3. Recall # D-879-2012;
5) Maximum Strength CONTAC Cold + Flu, (Acetaminophen 500mg, Chlorpheniramine Maleate 2mg and Phenylephrine HCl 5mg), 30 packets, 2 caplets per packet. UPC: 3-09711-232405-7. Recall # D-880-2012
6) Mejoralito, Children's Liquid (Acetaminophen), 2 fl oz bottles, Code: UPC: 0-53100-44310-9. Recall # D-881-2012;
7) Mejoralito, Children's Chewable Tablets (Acetaminophen), 80mg, 32 count bottles, UPC: 0-53100-44210-2. Recall # D-882-2012;
8) Women's Extra Strength PANADOL, Menstrual Relief, Multi-Symptom Caplets, (Acetaminophen 500mg, Pamabrom 25mg), 24 count bottles, UPC: 3-112843-21493-4; UPC: 3-12843-21494-1, UPC 3-09711-21491-2. Recall # D-883-2012
CODE
1) Lot number 0910000169, Exp. Date: Oct 2011; Lot: 0910000062, 0410000063, Exp. Date: Oct 2011, Lot: 0911000059, 0911000250, Exp. Date: Nov 2011, Lot: 1101000183, 1101000229, Exp. Date: Jan 2013, Lot:1103000366, Exp. Date; Feb 13, Lot: 1105000103, Exp. Date: May 2013; Lot 0910000056, 0410000057, 0410000058, 090000059, 0910000245, 0410000246, 0910000247, 0910000248, Exp. Date: Oct 2011, Lot: 1101000184, 1101000185, 1101000230, Exp. Date: Jan 2013, Lot: 1103000367, 1103000368, Exp. Date: Mar 2013;
2) Lot: PA015HE2, Exp. Date: May 2013; Lot: PA047FP1, Exp. Date: Dec 2012; Lot: PA047FP2, Exp. Date: Dec 2012;
3) Lot: 0911000230, 0911000232, Exp. Date: Nov 2011 and 1105000118, May 2013;
4) Lot: PA009HD2, Exp. Date: Oct 2012; Lot PA027HE2, Exp. Date: Nov 2012, Lot: PA065FP, Exp. Date Jun 2012; UPC: 3-09711-05015-2, Lot: PA006AHC1, Exp. Date: Sept 2012, Lot PA007HA1, Exp. Date: Jul 2012, Lot: PA008HD1, Oct 2012, Lot: PA009HB1, Exp. Date: 2012, Lot PA009HE1, Exp. Date: Nov 2012, Lot: PA010HB1, Exp. Date: Aug 2012, Lot: PA016FD1, Exp. Date: Oct 2011, Lot: PA029HE1, Exp. Date: Nov 2012, Lot: PA069FP1, Exp. Date: Jun 2012, Lot: PA070FP1, Exp. Date: Jun 2012, Lot: PA102FD2, Exp. Oct 2011, Lot: PA101FD1, Exp. Date: Oct 2011, Lot: PA102FD1, Exp. Date: Oct 2011;
5) Lot PA071FP1 and PA072FP1, Exp. Date: Jun 2012;
6) Lot: 1105000465, Exp. Date: May 2013and Lot: 0911000100, Exp. Nov 2011;
7) Lot: PA010HH2, Exp. Date 2013, Lot: PA011HE3, Exp. Date: May 2013, Lot: PA012HC2, Exp. Date: Mar 2013, Lot: PA064FP1, Exp. Date: Dec 2012 and Lot PA087FB1, Exp. Date: Feb 2012;
8) Lot: PA038EP1, Exp. Date: Dec 2011, Lot: PA073FP1, Exp. Date: Dec 2012; Lot: PA073FP2, Exp. Date: Dec 2012; Lot: PA085FB1, Exp. Date: Feb 2012 and Lot: PA098HC1, Exp. Date: Mar 2013
RECALLING FIRM/MANUFACTURER
Recalling Firm:GlaxoSmithKline Inc., Zebulon, NC, by letter on/about October 6, 2011.
Manufacturers: GlaxoSmithKline Panama S.A., Panama, Panama,
Manufacturer: GlaxoSmithKline Costa Rica, S.A., San Jose, Costa Rica. Firm initiated recall is ongoing.
REASON
cGMP Deviations; Some of the analytical process validation activities did not contain primary data.
VOLUME OF PRODUCT IN COMMERCE
602,578 units
DISTRIBUTION
Nationwide and PR
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III
___________________________________
PRODUCT
Suprep Bowel Prep Kit (sodium sulfate, potassium sulfate and magnesium sulfate) Oral Solution, 17.5g/3.13g/1.6g per 6 ounces, Kit contains: 2 6-ounce bottles of liquid bowel prep, 1 16-ounce mixing container, 1 patient booklet, Rx Only, NDC: 52268-012-01. Recall # D-837-2012
CODE
Lot #: 2811015, Exp. 07/13
RECALLING FIRM/MANUFACTURER
Braintree Laboratories, Inc., Braintree, MA, by letter on October 19, 2011. Firm initiated recall is ongoing.
REASON
Labeling: Correct Labeled Product Miscart/Mispack; Missing product labeling on white carton containing the kit contents. However, each kit carton is loaded with properly labeled Suprep oral solution bottles, patient instructions for use, package insert/medication guide and mixing container.
VOLUME OF PRODUCT IN COMMERCE
25,134 kit cartons
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Neomycin Sulfate Tablets, USP, 500 mg, Rx Only, Unit Dose 100 Tablets (10 Strips of 10 Tablets per carton), NDC 39822-0310-5. Recall # D-854-2012
CODE
Lot: FGX, Exp. 02/2012
RECALLING FIRM/MANUFACTURER
Recalling Firm: X-gen Pharmaceuticals Inc., Horseheads, NY, by letter and follow up telephone and e-mail on September 26, 2011.
Manufacturer: Patheon Inc. Whitby Operations, Whitby Ontario, Canada. Firm initiated recall is ongoing.
REASON
Discoloration: Some tablets were reported discolored resulting from improper sealing of the blister packaging.
VOLUME OF PRODUCT IN COMMERCE
1,443 Cartons
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Hydroxyzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, For Oral Use Only, Rx Only, a) 120 mL (4 fl. oz. bottle), NDC 0603-1310-54, b) 1 Pint (473 mL bottle), NDC 0603-1310-58. Recall # D-859-2012
CODE
Lot #s: a) L029E10C, Exp. 05/12; L100L10A, Exp. 01/13; b) L053E09B, Exp. 06/12; L005B10A, Exp. 02/13; L029E10B, L040E10A, Exp. 05/13; L095E10A, Exp. 06/13; L079J10A, Exp. 10/13
RECALLING FIRM/MANUFACTURER
Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals, Huntsville, AL, by letter on October 28, 2011. Firm initiated recall is ongoing.
REASON
Impurities/Degradation Products: Out of Specification results for an individual impurity at the 12 month room temperature time point.
VOLUME OF PRODUCT IN COMMERCE
30,740 Bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Rite Aid Pharmacy, laxative saline enema, monobasic sodium phosphate 19 g, dibasic sodium phosphate 7 g, 4.5 Fl oz (133 mL) Each, 12 bottles per box, NDC 11822489080.
Recall #D-870-2012;
2) Premier Value, Complete Ready to use Enema, Sodium Phosphates Rectal Solution, 4.5 fl oz (133 mL) Each, 3 bottles per box, NDC 68016-0021-45. Recall #D-871-2012
CODE
1) and 2) Lot Number 2021
RECALLING FIRM/MANUFACTURER
Natureplex LLC, Memphis, TN, by telephone and letter on October 18, 2011. Firm initiated recall is ongoing.
REASON
Superpotent (Multiple Ingredient) Drug
VOLUME OF PRODUCT IN COMMERCE
3910 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Source Plasma. Recall # B-0192-12
CODE
Units: 3780090507, 3780089977, 3780089217, 3780088121, 3780087860, 3780086972, 3780086711, 3780086182, 3780085661, 3780085400, 3780085022, 3780084650, 3780084245, 3780083970, 3780083532, 3780083230, 3780082799, 3780082524, 3780082137, 3780081898, 3780081498, 3780081271, 3780080895, 3780080736, 3780080051, 3780079048, 3780078760, 3780077682, 3780077197, 3780076788, 3780076382, 3780075954, 3780075798, 3780075292, 3780075060, 3780074497, 3780074128, 3780073614, 3780073199, 3780072683, 3780072386, 3780071930, 3780071773, 3780071235, 3780071023, 3780070482, 3780070035, 3780069531, 3780069202, 3780068030, 3780067868, 3780067155, 3780066906, 3780066329, 3780066104, 3780064570, 3780064281, 3780063596, 3780063261, 3780062676, 3780062341, 3780061837, 3780061514, 3780060974, 3780060627, 3780059912, 3780059703, 3780058987, 3780058746, 3780057852, 3780057646, 3780056971, 3780056610, 3780056072, 3780055783, 3780055171, 3780054619, 3780054231, 3780053773, 3780053430, 3780052974, 3780052348, 3780052032, 3780051473, 3780050380, 3780050062, 3780049496, 3780049280, 3780048689, 3780048123, 3780047643, 3780047160, 3780046752, 3780046276, 3780045484, 3780044929, 3780043951, 3780043627, 3780072914, 3780072720, 3780041374, 3780041005, 3780040561, 3780040083, 3780039726, 3780039341, 3780038911, 3780038379, 3780038183, 3780036877, 3780036076, 3780035942, 3780035508, 3780035170, 3780034699, 3780034376, 3780033719, 3780033460, 3780032804, 3780032622, 3780031976, 3780031798, 3780031302, 3780030989, 3780030792, 3780030111, 3780029906, 3780029287, 3780028817, 3780028117, 3780027857, 3780027407, 3780026057, 3780025807, 3780025050, 3780024797, 3780023810, 3780022997, 3780022284, 3780021909, 3780021292, 3780020947, 3780020232, 3780019971, 3780019297, 3780018968, 3780018295, 3780017765, 3780017221, 3780016546, 3780015963, 3780015287, 3780014579, 3780013978, 3780013423, 3780012753, 3780012127, 3780011547, 3780010898, 3780010286, 3780009746, 3780009174, 3780008578, 3780008155, 3780007574, 3780006993, 3780005695, 3780004952, 3780004525, 3780003930, 3780003504, 3780003084, 3780002601, 3780002097, 3780001769, 3780001295, 3780000967, 3780000497
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources Inc., Baton Rouge, LA, by facsimile on July 21, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who could not read English, were distributed.
VOLUME OF PRODUCT IN COMMERCE
178 units
DISTRIBUTION
NC
___________________________________
PRODUCT
1) Recovered Plasma. Recall # B-0235-12;
2) Red Blood Cells Leukocytes Reduced. Recall # B-0236-12
CODE
1) Unit: W038511342596;
2) Unit: W038511341596
RECALLING FIRM/MANUFACTURER
Walter L. Shepeard Community Blood Center, Inc., Augusta, GA, by fax on October 20, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had been permanently deferred, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
GA, FL
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-0238-12
CODE
Unit: W041011143288E; W041011143288E (double product)
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc dba United Blood Services, Scottsdale, AZ, by telephone and fax on September 18, 2011. Firm initiated recall is complete.
REASON
Blood products, incorrectly determined to be negative for the Jk (a) antigen, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AZ
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0252-12
CODE
Units: W158011702006; W158011702012
RECALLING FIRM/MANUFACTURER
Arup Laboratories, Inc., Sandy, UT, by electronic mail on October 11, 2011. Firm initiated recall is complete.
REASON
Blood products, collected using equipment that had not been validated, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
UT
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-0253-12
CODE
Unit: W158010106631
RECALLING FIRM/MANUFACTURER
Arup Laboratories, Inc., Sandy, UT, by electronic mail on September 7, 2011 and facsimile on September 19, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who may have traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
UT
___________________________________
PRODUCT
Platelets Pheresis. Recall # B-0254-12
CODE
Units: W120611013868 (part 1); W120611013868 (part 2)
RECALLING FIRM/MANUFACTURER
Michigan Blood, Grand Rapids, MI, by facsimile on September 20, 2011. Firm initiated recall is complete.
REASON
Blood products, which did not meet acceptable product specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MI
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-0256-12
CODE
Unit: W036311324310
RECALLING FIRM/MANUFACTURER
BloodCenter of Wisconsin, Inc., Milwaukee, WI, by letter on September 9, 2011 and facsimile on September 12, 2011. Firm initiated recall is complete.
REASON
Blood products, labeled RBC antigen negative tested RBC antigen positive, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WI
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-0257-12;
2) Recovered Plasma. Recall # B-0258-12
CODE
1) and 2) Unit: 004FX28242
RECALLING FIRM/MANUFACTURER
Recalling Firm: Arc Blood Services, New England Region, Dedham, MA, by fax on July 13, 2011 and e-mail on August 3, 2011.
Manufacturer: ARC Blood Services New England Region, Bangor, ME. Firm initiated recall is complete.
REASON
Blood products, processed from a unit of Whole Blood that was not appropriately tested for viral markers, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NH, CA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0272-12
CODE
Unit: 7052165
RECALLING FIRM/MANUFACTURER
Recalling Firm: New York Blood Center, inc-cellular Therapy Laboratory, New York, NY, by facsimile on July 30, 2007.
Manufacturer: New York Blood Center, Inc., Westbury, NY. Firm initiated recall is complete.
REASON
Blood product, which contained an insufficient plasma volume, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0274-12
CODE
Unit: W141608210984
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood Center, Seattle, WA, by e-mail on September 16, 2008.
Manufacturer: Puget Sound Blood Center and Program, Lynnwood, WA. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria
___________________________________
PRODUCT
1) Red Blood Cells. Recall # B-0276-12;
2) Fresh Frozen Plasma. Recall # B-0277-12
CODE
1) and 2) Unit: W141608392096
RECALLING FIRM/MANUFACTURER
Puget Sound Blood Center and Program, Seattle, WA, by facsimile on April 1, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
WA
___________________________________
PRODUCT
Red Blood Cells. Recall # B-0280-12
CODE
Unit: W001311004421
RECALLING FIRM/MANUFACTURER
Department of Air Force - BB/HT, Lackland A F B, TX, by facsimile on September 15, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0281-12
CODE
Unit: W035411057337
RECALLING FIRM/MANUFACTURER
Community Blood Center, Dayton, OH, by telephone on September 12, 2011. Firm initiated recall is complete.
REASON
Blood product, which was labeled with an extended expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0282-12
CODE
Unit: 12FX37858
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Carolinas Region, Charlotte, NC, by letter dated October 21, 2011.
Manufacturer: American Red Cross Blood Services, Durham, NC. Firm initiated recall is complete.
REASON
Blood product, collected in a manner that may have compromised the sterility of the unit, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-0286-12;
2) Red Blood Cells Leukocytes Reduced. Recall # B-0287-12
CODE
1) Unit: W043211043728;
2) Unit: W043211022544
RECALLING FIRM/MANUFACTURER
Blood Assurance Inc., Chattanooga, TN, by facsimile on October 13, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
IN, TN
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0289-12
CODE
Unit: 50LZ37938
RECALLING FIRM/MANUFACTURER
American National Red Cross, Toledo, OH, by telephone on September 12, 2011 and by letter dated September 12, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0237-12;
CODE
Unit: 12FW67307
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Charlotte, NC, by letter dated September 16, 2011.
Manufacturer: American Red Cross Blood Services, Durham, NC. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Platelets Pooled Irradiated. Recall # B-0270-12
CODE
Unit: W141608531296
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood Center and Program, Seattle, WA, by facsimile on April 4, 2008.
Manufacturer: Puget Sound Blood Center and Program, Tukwila, WA, Firm initiated recall is complete.
REASON
Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0271-12
CODE
Units: LQ79647, LQ79650, LQ79653, LQ79654, LQ79663, LQ81826, LQ81825, LQ81827, LQ81828
RECALLING FIRM/MANUFACTURER
Sacramento Medical Foundation, Sacramento, CA, by facsimile on August 13, 2007. Firm initiated recall is complete.
REASON
Blood products, which were incorrectly tested for human T lymphotropic virus, types I and II (HTLV-I/II), were distributed.
VOLUME OF PRODUCT IN COMMERCE
9 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells. Recall # B-0273-12
CODE
Units: W035808016403, W035808124271, W035808016411, W035808016412, W035808030178, W035808124270
RECALLING FIRM/MANUFACTURER
BloodSource, Inc., Mather, CA, by telephone on October 14, 2008. Firm initiated recall is complete.
REASON
Blood products, which may have been exposed to unacceptable storage temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells. Recall # B-0275-12
CODE
Unit: W141608453777
RECALLING FIRM/MANUFACTURER
Puget Sound Blood Center and Program, Seattle, WA, by facsimile on July 17, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor with an elevated body temperature, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WA
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0279-12
CODE
Unit: 12J22026
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Carolinas Region, Charlotte, NC, by letter on September 15, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0283-12
CODE
Unit: W227710341900
RECALLING FIRM/MANUFACTURER
Mid-South Regional Blood Center, Memphis, TN, by facsimile on August 31, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who received the shingles vaccine, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-0284-12
CODE
Unit: W036511089524 (2 units)
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Monroe, LA, by letter dated October 18, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with polycythemia, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
LA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-0285-12
CODE
Units: 29GS94211, 29GY83519, 29GY83520, 29KG05016, 29GS94209
RECALLING FIRM/MANUFACTURER
American National Red Cross Mid Atlantic Region, Norfolk, VA, by telephone on August 24, 2011 and by letter dated August 24, 2011. Firm initiated recall is complete.
REASON
Blood products, labeled with an extended expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
CA, VA
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0288-12
CODE
Units: W043211043728; Unit: W043211022544
RECALLING FIRM/MANUFACTURER
Blood Assurance Inc., Chattanooga, TN, by facsimile on October 13, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
IN, TN
RECALLS AND FIELD CORRECTIONS: DEVICES – CLASS II
___________________________________
PRODUCT
1) Probe, Tactile, Left, ASM, Long, Part #962009S. Trackable hand held instruments used in spine surgeries for preparation of the pedicle. These instruments are used in conjunction with the Medtronic Navigation StealthStation platform and various software applications. Recall # Z-0001-2012;
2) Probe, Tactile, Right, ASM, Long, Part #962011S. Trackable hand held instruments used in spine surgeries for preparation of the pedicle. These instruments are used in conjunction with the Medtronic Navigation StealthStation platform and various software applications. Recall # Z-0002-2012
CODE
1) Lot Number 090106;
2) Lot Number 071219
RECALLING FIRM/MANUFACTURER
Medtronic Navigation, Inc., Louisville, CO, by letter dated Jan 20, 2011. Firm initiated recall is complete.
REASON
Distal end of tactile probe may break off during use.
VOLUME OF PRODUCT IN COMMERCE
12 probes
DISTRIBUTION
Nationwide and South Korea
___________________________________
PRODUCT
Thermo Scientific Microm: Rotary Microtome: REF HM355S-3 Used for slicing tissue blocks. Recall # Z-0039-2012
CODE
Serial Numbers: 34450, 34519, 34520, 34601, 34662, 34665, 34807, 34922, 35030, 35032, 35033, 35159, 35637, 35793, 35976, 35978, 35978, 38337, 38584, 38651, 39238, 39280, 39281, 39542, 39795, 40607, 41039, 45104, 45367, 45369, 45371, 45760, 45845, 47466, 47467, 47468, 47469, 47772, 47773, 47774, 47775, 47776, 48095, 48096, 48097, 48098, 48109, 48110, 48111, 48112, 48113, 48114, 48115, 48116, 48184, 48252, 48253, 48254, 48259, 48260, 48261, 48314, 48315, 48593, 48594, 48910, 48911, 48912, 48913, 48914, 48915, 48916, 48917, 48918, 48919, 48920, 48921, 48922, 48923, 48924, 48978, 48978, 49102, 49103, 49104, 49105, 49106, 49107, 49108, 49109, 49110, 49209, 49209, 49210, 49210, 49211, 49211, 49212, 49213, 49213, 49214, 49214, 49221, 49223, 49230, 49286, 49287, 49288, 49289, 49290, 49291, 49292, 49293, 49294, 49295, 49296, 49297, 49298, 49299, 49300, 49301, 49302, 49303, 49304, 49305, 49306, 49307, 49308, 49309, 49310, 49311, 49312, 49962, 49963, 49964, 49965, 49966, 49967, 49968, 49969, 49970, 49971, 49972, 49973, 49974, 49975, 49976, 49977, 49978, 49989, 49990, 49991, 49992, 49993, 49994, 49995, 50221, 50222, 50224, 50225, 50226, 50578, 50579, 50580, 50581, 50582, 50583, 50584, 50585, 50586, 50587, 50676, 50677, 50678, 50679, 50680, 50681, 50791, 50792, 50793, 50794 and 50911
RECALLING FIRM/MANUFACTURER
Recalling Firm: Richard-Allan Scientific Co., Kalamazoo, MI, by letter on August 12, 2011.
Manufacturer: Microm International Gmbh, Walldorf, Germany. Firm initiated recall is ongoing.
REASON
The firm has received two complaints of finger lacerations in operators of this device.
VOLUME OF PRODUCT IN COMMERCE
786 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Medtronic Arctic Front Catheter, Sterile EO, Model 2AF282 and 2AF231 ( not distributed in US) Product Usage: The Medtronic CryoCath System consists of a Cryoablation console, cardiac Cryoablation catheters, connection components and accessories. The Arctic Front Cardiac Cryoablation Catheter is an over the wire Balloon catheter. The inside of the Balloon at the distal end of the Cryoablation Catheter reaches temperatures of -50 C or colder when refrigerant is injected from the console to the inside of the balloon. Arctic Front Cardiac Cryoablation catheters are introduced into the vasculature by traditional minimally invasive techniques. The CryoConsole houses the electrical and mechanical components as well as proprietary software for controlling and recording a cryotherapy procedure with Arctic Front and/or the Freezor family of catheters. It stores and controls the delivery of the liquid refrigerant through the coaxial umbilical to the catheter, recovers the refrigerant vapor from the catheter under constant vacuum, and disposes of the refrigerant through the hospital scavenging system. Multiple features are built into the catheter and the CryoConsole system to ensure safety. Model Number: 2AF282. Recall # Z-0149-2012
CODE
Lots 21571, 25375, 25376, 25377, and 25381
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic Inc. Cardiac Rhythm Disease Management, Saint Paul, MN, by letter dated August 2011, hand delivered by Medtronic Field Representatives on August 29, 2011.
Manufacturer: Medtronic CryoCath LP, Kirkland, Canada. Firm initiated recall is ongoing.
REASON
Product distributed with incorrect programming that may result in false expired catheter notifications.
VOLUME OF PRODUCT IN COMMERCE
263 units
DISTRIBUTION
Nationwide, Austria, United Kingdom
___________________________________
PRODUCT
ProScreen PSCup-5M Waived, Catalog Number: PSCup-5M Waived Product Usage: The ProScreen Drugs of Abuse Test Cup is a one-step immunoassay for the qualitative detection of multiple drugs in human urine (refer to PN: 42141-PS-W). The ProScreen Drugs of Abuse Test Cup is used to obtain a visual, qualitative result and is intended for professional use only. The ProScreen Drugs of Abuse Cup is not for legal or medical diagnostic purposes. This device is not intended for workplace testing. For diagnostic and treatment purposes, consult with a healthcare or substance abuse professional. This assay provides only a preliminary result. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectroscopy (GC/MS) is the preferred confirmation method. Recall # Z-0152-2012
CODE
Lot # 102608
RECALLING FIRM/MANUFACTURER
Ameditech Inc., San Diego, CA, by letter on June 9, 2011. Firm initiated recall is ongoing.
REASON
The recalled products are mislabeled. If the USD customer receives the FirstCheck tes, there will be no instructions for use for the test.
VOLUME OF PRODUCT IN COMMERCE
2000 Test Cups (800 kits)
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
ARCHITECT Cyclosporine; an in-vitro diagnostic chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of cyclosporine in human whole blood Distributed by Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064 USA; list 1L75-25. The ARCHITECT Cyclosporine assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of cyclosporine in human whole blood on the ARCHITECT i System. The ARCHITECT Cyclosporine assay is used as an aid in the management of heart, liver and kidney transplant patients receiving cyclosporine therapy. Recall # Z-0162-2012
CODE
Lots 95098M500 exp 12/21/2011; 96143M500 exp 01/20/2012; 96142M500 exp 01/20/2012; 01107M500 exp 02/24/2011; 02079M500 exp 02/24/2012; 03182M500 exp 05/19/2012; 05533M500 exp 05/19/2012; 04069M500 exp 06/02/2012; 06525M500 exp 06/02/2012; 05014M500 exp 06/23/2012; 07011M500 exp 06/23/2012
RECALLING FIRM/MANUFACTURER
Recalling Firm: Abbott Laboratories, Abbott Park. IL, by letter dated October 7, 2011.
Manufacturer: Fujirebio Diagnostics, Inc., Malvern, PA. Firm initiated recall is ongoing.
REASON
The ARCHITECT Cyclosporine assay has the potential to generate falsely elevated or depressed results with patient samples due to precision exceeding the Package Insert claim of <15% total CV. Calibrators and Controls also have the potential to be impacted by the assay imprecision.
VOLUME OF PRODUCT IN COMMERCE
8,913 kits
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
1) BioPro Femoral Head 28 mm -6 mm, Item 19003. Orthopedic femoral head for implantation. Recall # Z-0163-2012;
2) BioPro Femoral Head 28 mm +18, Item 19010. Orthopedic femoral head for implantation. Recall # Z-0164-2012
CODE
1) Lot 108327, Serial Number 0007-0014;
2) Lot 108329, Serial Number 0001-0016
RECALLING FIRM/MANUFACTURER
Biopro, Inc., Port Huron, MI, by telephone on September 21, 2011 and by letter dated September 29, 2011. Firm initiated recall is complete.
REASON
BioPro Femoral Head Outer Packaging was found lacking proper seal ,compromising sterility.
VOLUME OF PRODUCT IN COMMERCE
12 units
DISTRIBUTION
FL, MI, TX
___________________________________
PRODUCT
1) Abbott brand IntraLase Femtosecond Laser System, Model 2; Catalog Numbers: 20003D/J/K, R20003D/J/K, 20005D/J/K; Product Usage: Intended Use for: IntraLase Femtosecond (Model 2 and 3) and iFS Advanced Femtosecond Laser Systems. FS Laser Systems are ophthalmic surgical lasers used in certain patient populations: (1) In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea; (2) In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments; (3) In lamellar IEK [lntraLase Enabled Keratoplasty] and corneal harvesting ; (4) In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea; (5) In the creation of a lamellar cut/resection of the cornea for lamellar IEK for the creation of a penetrating cut/incision for penetrating IEK. Recall # Z-0165-2012;
2) Abbott brand IntraLase Femtosecond Laser System, Model 3; Catalog Numbers: 20004D/J/K, R20004J/K; Product Usage: Intended Use for: IntraLase Femtosecond (Model 2 and 3) and iFS Advanced Femtosecond Laser Systems. FS Laser Systems are ophthalmic surgical lasers used in certain patient populations: (1) In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea; (2) In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments; (3) In lamellar IEK (lntraLase Enabled Keratoplasty) and corneal harvesting; (4) In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea; (5) In the creation of a lamellar cut/resection of the cornea for lamellar IEK for the creation of a penetrating cut/incision for penetrating IEK. Recall # Z-0166-2012;
3) Abbott brand Advanced Femtosecond Laser Systems, Model iFS, Catalog Number: J20007D/J/K; Product Usage: Intended Use for: IntraLase Femtosecond (Model 2 and 3) and iFS Advanced Femtosecond Laser Systems. FS Laser Systems are ophthalmic surgical lasers used in certain patient populations: (1) In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea; (2) In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments; (3) In lamellar IEK [lntraLase Enabled Keratoplasty] and corneal harvesting ; (4) In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea; (5) In the creation of a lamellar cut/resection of the cornea for lamellar IEK for the creation of a penetrating cut/incision for penetrating IEK. Recall # Z-0167-2012
CODE
All units of these models (models 2, 3 and iFS) except model 1.
RECALLING FIRM/MANUFACTURER
AMO Manufacturing USA, LLC, Milpitas, CA, by letter dated October 12, 2011. Firm initiated recall is ongoing.
REASON
The firm has identified a discrepancy in cut depth that may affect deep corneal incisions (e.g. 300 m or deeper) created using the Laser System.
VOLUME OF PRODUCT IN COMMERCE
1226 total laser systems
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Baxter System 1000 Tina Single Patient Hemodialysis Delivery System; product code S1000L3P. Hemodialysis and Continuous Renal Replacement Therapy devices for acute and chronic hemodialysis. Recall # Z-0173-2012
CODE
Serial Number 28130
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Renal Div., McGaw Park, IL, by visit on September 19, 2011.
Manufacturer: Baxter Healthcare Corp., Largo, FL. Firm initiated recall is complete.
REASON
The Tina System was released to the customer with OOS values for the Pressure Displays Accuracy and Leakage Rate Test.
VOLUME OF PRODUCT IN COMMERCE
1 system
DISTRIBUTION
PR
__________________________________
PRODUCT
1.0mL 28 G x 1/2" blister packaged insulin syringe, Catalog Number 329424; Intended use: Subcutaneous injection of insulin. K024112 D039612. Recall # Z-0174-2012
CODE
Lot # 0039920
RECALLING FIRM/MANUFACTURER
Recalling Firm: Becton Dickinson & Co., Franklin Lakes, NJ, byletter dated June 15, 2011.
Manufacturer: BD Medical - Diabetes Care, Holdrege, NB. Firm initiated recall is ongoing.
REASON
Experiment labels may be on shelf cartons of 1.0ml 28G x 1/2 blister packaged insulin syringes.
VOLUME OF PRODUCT IN COMMERCE
10,230 shelf cartons (1,023,000 syringe units)
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Stryker Mantis Rod Inserter Assembly Stryker Mantis Rod Inserter Inner Shaft IS2097MAN Mantis Rod Inserter Shaft Used to facilitate insertion and delivery of a Mantis rod. Recall # Z-0175-2012
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Spine, Allendale, NJ, by letter, dated June 24, 2011.
Manufacturer: Stryker Spine, Cestas, Aquitane, France. Firm initiated recall is ongoing.
REASON
There have been reports of difficulty in rod rotation using the newly designed Mantis Rod Inserter.
VOLUME OF PRODUCT IN COMMERCE
471 units nationwide; 667 units international
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Clinical Chemistry Urea Nitrogen a) List Number 7D75-21 and b) 7D75-31 used for the Quantitation of urea nitrogen in human serum, plasma, and urine. Recall # Z-0189-2012 CODE
a) Lot 97642UN11; and b) lot 97668UN11
RECALLING FIRM/MANUFACTURER
Recalling Firm: Abbott Laboratories, Inc., Irving, TX, by letterson October 3, 2011.
Manufacturers: Thermofisher Scientific, Middletown, VA;
Abbott Laboratories, Abbott Park, IL. Firm initiated recall is ongoing.
REASON
The reagents are being recalled due to particulate matter in some of the reagent cartridges. The particulate matter has been identified as Aureobasidium fungus species.
VOLUME OF PRODUCT IN COMMERCE
5704 units
DISTRIBUTION
Nationwide and Internationally
__________________________________
PRODUCT
DICOM Option for the Norland Illuminatus Software Revs 4.2.0 though 4.3.1. Models Norland XR-600, XR-800, XR-46, EXCELL, XR-36 and Eclipse DXA Bone Densitometers. The XR 46 performs DXA scans of the AP Spine, Hip, Forearm, Lateral Spine, and Whole Body, as well as other user selectable sites. It provides BMD (g/cm2), Area (cm2), and BMC (g) values. It compares these values to gender and ethnic matched reference populations and provides T-Score and % young Reference, Z- Score and % age matched, and long term and short term change values. This includes sBMD (mg/cm2). The XR 46 performs soft tissue assessment and provides lean mass, fat mass, percent fat, and total soft tissue values for all scan sites, including Whole Body. The XR 46 includes a Report writer that allows the operator to customize the appearance of their report stand to automate the tedious part of the report. It also allows the user to enter ranges of patient values and the specific statements they want to be printed on their report for each of these ranges. The bone density measurements from the XR 46 can be used as an aid to physicians in determining fracture risk. Part Number 434A133. Recall #Z-0213-2012
CODE
Scanner S/N Scanner Type 3602 Eclipse 3730 Eclipse 3734 Eclipse 3763 Eclipse 3807 Eclipse 3862 Eclipse 3863 Eclipse 3873 Eclipse 3912 Eclipse 4006 Eclipse 4100 Eclipse 4216 Eclipse 4231 Eclipse 4258 Eclipse 4295 Eclipse 4296 Eclipse 4340 Eclipse 3796 Eclipse 1027 Excell 1028 Excell 1073 Excell 1088 Excell 1115 Excell 1117 Excell 1122 Excell 1124 Excell 1142 Excell 1163 Excell 1180 Excell 1187 Excell 1213 Excell 1296 Excell 1307 Excell 1360 Excell 1372 Excell 1383 Excell 1405 Excell 1437 Excell 1446 Excell 1472 Excell 1483 Excell 1496 Excell 1527 Excell 1601 Excell 1605 Excell 1637 Excell 1644 Excell 1658 Excell 1676 Excell 1679 Excell 1685 Excell 1687 Excell 1735 Excell 1741 Excell 1793 Excell 1807 Excell 1819 Excell 1846 Excell 1878 Excell 1931 Excell 1934 Excell 1938 Excell 1954 Excell 1954 Excell 1971 Excell 1998 Excell 2004 Excell 2005 Excell 2016 Excell 2017 Excell 2027 Excell 2029 Excell 2031 Excell 2032 Excell 2033 Excell 2034 Excell 2035 Excell 6782 XR-36 6914 XR-36 8501 XR-36 6960CE XR-36 8005 XR-46 8017 XR-46 8066 XR-46 8147 XR-46 8148 XR-46 8162 XR-46 8188 XR-46 8216 XR-46 8325 XR-46 8329 XR-46 8331 XR-46 8334 XR-46 8335 XR-46 8511 XR-600 20000 XR-600 20001 XR-600 20002 XR-600 20005 XR-600 20013 XR-600 20018 XR-600 20020 XR-600 20022 XR-600 20023 XR-600 20024 XR-600 20028 XR-600 20032 XR-600 20034 XR-600 20036 XR-600 20047 XR-600 20048 XR-600 20049 XR-600 20051 XR-600 20052 XR-600 20057 XR-600 20059 XR-600 20060 XR-600 20064 XR-600 20067 XR-600 20069 XR-600 20070 XR-600 20073 XR-600 20074 XR-600 20077 XR-600 20078 XR-600 20079 XR-600 20082 XR-600 20085 XR-600 20087 XR-600 20090 XR-600 20094 XR-600 20102 XR-600 20104 XR-600 20108 XR-600 20116 XR-600 20121 XR-600 20133 xr-600 20135 XR-600 20138 XR-600 20140 XR-600 8502 XR-800 8506 XR-800 8514 XR-800 8515 XR-800 8523 XR-800 8524 XR-800 8531 XR-800 8532 XR-800 8533 XR-800 8537 XR-800 8543 XR-800 8547 XR-800 8549 XR-800 8551 XR-800 8552 XR-800 8553 XR-800 8556 XR-800 8558 XR-800 8559 XR-800 8560 XR-800 8561 XR-800 8562 XR-800 8563 XR-800 8565 XR-800 8566 XR-800 8567 XR-800 8569 XR-800 8571 XR-800 8572 XR-800 8577 XR-800 8579 XR-800 8582 XR-800 8583 XR-800 8584 XR-800 8587 XR-800 8588 XR-800 8591 XR-800 8596 XR-800 8597 XR-800 8599 xr-800 8600 xr-800 8604 XR-800 8611 XR-800 8614 XR-800
RECALLING FIRM/MANUFACTURER
Recalling Firm: Cooper Surgical, Inc., Trumbull, CT, by letter dated September 23, 1011.
Manufacturer: Norland, A CooperSurgical Co., Fort Atkinson, WI. Firm initiated recall is ongoing.
REASON
The DICOM Software, could lead to improper patient information getting into a previous patient's record.
VOLUME OF PRODUCT IN COMMERCE
14 units
DISTRIBUTION
Nationwide and Internationally
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PRODUCT
Software: SA BASE 3.1.4.x, 3.1.6.x and SA LabMic 4.0.0.x, 4.0.1.x, 4.0.2.x, 4.0.3.x, 4.0.4.x. SoftLab is a laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained, and experienced personnel. SoftLab enables the user to handle data-processing and laboratory activities, for the purpose of storing, managing, querying, and reporting laboratory data. Recall # Z-0261-2012
CODE
Versions: SA BASE 3.1.4.x, 3.1.6.x and SA LabMic 4.0.0.x, 4.0.1.x, 4.0.2.x, 4.0.3.x, 4.0.4.x.
RECALLING FIRM/MANUFACTURER
SCC Soft Computer, Clearwater, FL, via the SCC Soft Computer proprietary Task management system on August 8, 2011. Firm initiated recall is ongoing.
REASON
A client reported a flagging error where the result was flagged as critical in the Instrument Menu but the printed report did not show the corresponding flag.
VOLUME OF PRODUCT IN COMMERCE
255 units
DISTRIBUTION
Nationwide and Canada
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PRODUCT
Boston Scientific Super Sheath and Super Sheath R/O Introducer Sheaths, Sterile EO, a) Super Sheath 8F x 11 cm, 038 with Guide Wire BX/10 UPN H7491603508B1, Catalog # 16035-08B; b) Super Sheath 8F x 11 cm ,038 without Guide Wire BX/10 , U PN M00115724B1, Catalog # 15-724B1; c) Super Sheath R/O 8 F x 11 cm without Guide Wire BX/10, M00159664B1, Catalog # 15-964B. The device is indicated for use in the introduction of diagnostic and interventional devices inserted into the human vasculature.
Recall # Z-0264-2012
CODE
Lots: a) 11B15B6 11B23B7 11B28B9 11C09BA 11C16B9 11C30B9; b) 11C07B8; c) 11B01B4 11B25B6
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific Corp., Maple Grove, MN, by letter dated November 21, 2011.
Manufacturer: Togo Medikit Co., Ltd., Miyazaki-ken, Japan. Firm initiated recall is ongoing.
REASON
Boston Scientific was informed through product complaints that the 0.035" ID dilator may be labeled incorrectly as a 0.038" ID dilator.
VOLUME OF PRODUCT IN COMMERCE
2,660 kits
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Draeger Infinity(R) Delta, Delta XL, Gamma XXL and Kappa Monitors are used to monitor, physiologically, the vital signs of patients (with Arrhythmia Detection or Alarms). Catalog Number(s): MS18597 and MS18852. Recall # Z-0281-2012
CODE
Software versions: VF6.2, VF6.3, VF6.4, VF7.1 and VF7.2
RECALLING FIRM/MANUFACTURER
Draeger Medical, Inc., Telford, PA, by letter on October 25, 2011. Firm initiated recall is ongoing.
REASON
Complaints reporting Ventricular Fibrillation (Vfib) arrhythmias were not recognized by the monitor and did not alarm when the Masimo SET pod is used for SpO2. measurements.
VOLUME OF PRODUCT IN COMMERCE
14,894
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
1) DePuy Mitek Panalock Loop, Lupine Anchor Catalog #210704 The LUPINE BR Anchor System is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization. Recall # Z-0314-2012;
2) DePuy Mitek Lupine Loop Plus w/ Orthocord Catalog #210708 The LUPINE BR Anchor System is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization. Recall # Z-0315-2012;
3) DePuy Mitek Lupine Loop Plus w/ Orthocord DS Catalog #210709 The LUPINE BR Anchor System is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization. Recall # Z-0316-2012;
4) DePuy Mitek Lupine Loop Rapide w/ Orthocord Catalog #210711 The LUPINE BR Anchor System is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization. Recall # Z-0317-2012;
5) DePuy Mitek Panalock Loop w/ Orthocord Catalog #222980 The LUPINE BR Anchor System is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization. Recall #Z-0318-2012
CODE
1) Lot # 3549274;
2) Lot # 3549296;
3) Lot # 3549732;
4) Lot # 3549273, 3549621;
5) Lot # 3547740
RECALLING FIRM/MANUFACTURER
Recalling Firm: DePuy Mitek, Inc., a Johnson & Johnson Co., Raynham, MA, by letter dated October 31, 2011.
Manufacturer: Ethicon SARL, Neuchtel, Switzerland. Firm initiated recall is ongoing.
REASON
Incorrect suture configuration.
VOLUME OF PRODUCT IN COMMERCE
1,768 units
DISTRIBUTION
Nationwide and Internationally
RECALLS AND FIELD CORRECTIONS: DEVICES – CLASS III
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PRODUCT
1) 37% Etching Gel-1ml syringe, part # T06 The intended use of these devices is to etch tooth dentin/enamel in order to prepare the tooth surface prior to the application of a bonding agent. Recall # Z-0153-2012;
2) 37% Etching Gel-1ml syringe 20 pk, part # T06A The intended use of these devices is to etch tooth dentin/enamel in order to prepare the tooth surface prior to the application of a bonding agent. Recall # Z-0154-2012;
3) 37% Etching Gel-1ml syringe 50 pk, part # T06B The intended use of these devices is to etch tooth dentin/enamel in order to prepare the tooth surface prior to the application of a bonding agent. Recall # Z-0155-2012;
4) 37% Etching Gel-3ml syringe, part #N01H The intended use of these devices is to etch tooth dentin/enamel in order to prepare the tooth surface prior to the application of a bonding agent. Recall:# Z-0156-2012;
5) 37% Etching Gel-5ml syringe, part #N01IB The intended use of these devices is to etch tooth dentin/enamel in order to prepare the tooth surface prior to the application of a bonding agent. Recall # Z-0157-2012
CODE
All lots of products labeled as 37% Phosphoric Acid Etching Gel produced since April 2007
RECALLING FIRM/MANUFACTURER
Kerr/pentron Dba Kerr Corporation and Pentron Clinical, Orange, CA. by letter dated May 31, 2011. Firm initiated recall is ongoing.
REASON
Pentron Clinical is voluntarily recalling all lots of products labeled as 37% Phosphoric Acid Etching Gel produced since April 2007 because the product continues to extrude out of the syringe even after pressure is no longer applied, and it contains a higher percentage of phosphoric acid than that indicated on the label.
VOLUME OF PRODUCT IN COMME RCE
41,744 units
DISTRIBUTION
Nationwide and Internationally
END OF ENFORCEMENT REPORT FOR DECEMBER 7, 2011
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