FDA

Enforcement Report

The FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.


JUNE 19, 2002 02-24

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I

_______________________ PRODUCT Uncooked shrimp in plastic bag labeled in part "Uncooked SHRIMP Individually Quick Frozen 26/30 Shrimp Per LB Northern King Brand NET WT. 32 OZ (2 LBS.) Product is packed 10/2 lb. bags/case. Recall # F-479-2. CODE The cases are coded: 106180, 107183, 107184, 107185, and 107190. The individual 2 lb. bags are not coded. RECALLING FIRM/MANUFACTURER Tai Foong USA, Inc., Seattle, WA, by letter on October 24, 2001 and by press release on December 18, 2001. State initiated recall is complete. REASON The New York State Department of Agriculture and Markets determined that the product contained undeclared sulfites. VOLUME OF PRODUCT IN COMMERCE 1800 cases. DISTRIBUTION NY, NJ and PA. _______________________ PRODUCT Tuna Salad Sandwiches, Net Weight 4 Oz. Recall # F-481-2. CODE Expiration date on 1/6. RECALLING FIRM/MANUFACTURER Avanti Foods/Lepine Food Corp., Milwaukee, WI, by telephone on January 4, 2002. Firm initiated recall is complete. REASON The product contained undeclared eggs and FD&C Yellow # 5. VOLUME OF PRODUCT IN COMMERCE 27 sandwiches DISTRIBUTION WI. _______________________ PRODUCT Frozen Dough for Cinnamon Biscuits with Icing sold under two brands - Bob Evans and Owens. The product is packaged in a tin with a printed lid, 7 biscuits per tin and 6 tins per case. NET WT 1 LB 6.25 OZ (631 g). Recall # F-482-2. CODE All codes that end in "1". RECALLING FIRM/MANUFACTURER Recalling Firm: CH Guenther and Son, Inc., San Antonio, TX, by letter dated December 5, 2001. Firm initiated recall is complete. REASON Undeclared whey. VOLUME OF PRODUCT IN COMMERCE 6000 cases. DISTRIBUTION Nationwide. _______________________ PRODUCT Lucerne brand Mud Pie Ice Cream, packaged in paperboard square one-gallon carton. Recall # F-483-2. CODE Best Before May 17/02. RECALLING FIRM/MANUFACTURER Recalling Firm: Safeway, Inc., Pleasanton, CA, by e-mail on October 25, 2001. Manufacturer: Safeway Inc., Capitol Heights, MD. Firm initiated recall is complete. REASON The product may contain undeclared peanuts. VOLUME OF PRODUCT IN COMMERCE 458 cases (2,746 units). DISTRIBUTION IL. _______________________ PRODUCT Wing Shing brand Dried Lily Flower packed in flexible plastic packages, net wt. 6 oz. (170 g). Ingredients: Lily Flower. Product of China. Recall # F-484-2. CODE Barcode # 4 892733 701806 and no other coding. RECALLING FIRM/MANUFACTURER Recalling Firm: Wing Shing Hong, Inc., Brooklyn, NY, by issuing an Allergen Alert on July 18, 2001 and by letter on July 25, 2001. Manufacturer: Wing Shing Foods Ltd., Dong Guan City, Guang Dong. State initiated recall is complete. REASON The product contained undeclared sulfites. VOLUME OF PRODUCT IN COMMERCE 127 cases (100 - 6 oz. packages per case). DISTRIBUTION CA. _______________________ PRODUCT Fortuner’s Selected Food brand Dried Lily Flower packaged in flexible plastic bags, net wt. 6 oz. Made in China. Recall # F-485-2. CODE None. RECALLING FIRM/MANUFACTURER Recalling Firm: Fortuner's Food Co., Inc., Brooklyn, NY, by press release on July 16, 2001 and by letter on July 23, 2001. Manufacturer: Qingdao Native Product I/E Co., Qingdao, Shangdong. State initiated recall is complete. REASON The product contained undeclared sulfites. VOLUME OF PRODUCT IN COMMERCE 40 cases (100 x 6 oz. bags per case). DISTRIBUTION NY. _______________________ PRODUCT a) Al Cohen's Delicious Enriched Dinner Rolls, Net Wt. 15 oz. Recall # F-486-2; b) Al Cohen's Delicious Enriched Onion Rolls, Net Wt. 21 oz. Recall # F-487-2; c) Al Cohen's Delicious Enriched 8 Twist Rolls, Net Wt. 21 oz. Recall # F-488-2. These are sold in plastic bags/12 rolls per bag. CODE Sell by 2/23 Sell by 2/24. RECALLING FIRM/MANUFACTURER Cohen's Bakery, Inc., Buffalo, NY, by visit on February 21 and February 22, 2002. State initiated recall is complete. REASON Undeclared whey and nonfat dry milk. VOLUME OF PRODUCT IN COMMERCE Unknown. DISTRIBUTION NY. _______________________ PRODUCT Zurheide Rowdy Reindeer Ice Cream, half gallon, in round paper container. Recall # F-489-2. CODE The product is in half gallon containers with 2671 on the bottom. RECALLING FIRM/MANUFACTURER Zurheide Ice Cream Company, Inc., Sheboygan, WI, by telephone on April 23 and 24, 2002. Firm initiated recall is complete. REASON Undeclared peanuts VOLUME OF PRODUCT IN COMMERCE 1413 half gallons. DISTRIBUTION IL and WI. _______________________ PRODUCT The product is canned soup, labeled in part: "READY TO SERVE CLASSIC TOMATO SOUP NET WT. 18.7 OZ. Recall # F-490-2. CODE The code is found as two lines on the bottom of the can, where XX:XX is military time: NOV 2002 11211 CT KSYT XX:XX. RECALLING FIRM/MANUFACTURER Recalling Firm: Campbell Soup Co., Camden, NJ, by letter dated February 8, 2002. Manufacturer: Campbell Soup Supply Co, LLC Paris, TX. Firm initiated recall is complete. REASON Product contains undeclared soy and milk ingredients. VOLUME OF PRODUCT IN COMMERCE 240,000. DISTRIBUTION Nationwide. _______________________ PRODUCT Awrey's brand Date Oatmeal Bars 8 pack, Net Wt. 12 oz. in cardboard tray and overrated with cellophane. Recall # F-491-2. CODE Use by date 1/31/02. RECALLING FIRM/MANUFACTURER Recalling Firm: Koepplinger's Bakery, Inc., Oak Park, MI, by press release on January 25, 2002. Manufacturer: Awrey's Bakeries, Inc., Livonia, MI. Firm initiated recall is complete. REASON Undeclared walnuts. VOLUME OF PRODUCT IN COMMERCE 18 cases (360 packages). DISTRIBUTION MI. _______________________ PRODUCT Mueller's Yolk Free Noodle Style Pasta - Medium and Wide, 12 oz bags, packaged 12 bags per cases. The affected package is a "Stand Up Block Bottom Bag". Recall # F-492-2. CODE a) Mueller's Yolk Free Noodle Style Pasta - Medium - Lot codes 082303Y, and 112103Y. The UPC Code is 02965026; b) Mueller's Yolk Free Noodle Style Pasta - Wide - Lot Codes 082403Y, 102203Y, 112003Y, 1219O3Y, and 122003Y. The UPC Code is 02965123. RECALLING FIRM/MANUFACTURER Recalling Firm: American Italian Pasta Co., Kansas City, MO, by press release and e-mail on December 21, 2001. Manufacturer: American Italian Pasta Co., Columbia, SC. Firm initiated recall is complete. REASON Product contains undeclared egg whites. VOLUME OF PRODUCT IN COMMERCE a) 873/12-pkg. cases of the medium pasta; b) 6,833/12-pkg. cases of the wide pasta. DISTRIBUTION Nationwide. _______________________ PRODUCT Silver Spoon Salad Co., Inc. 5 lb. containers of: a) Seafood Salad, Product Number: 4509. Recall # F-493-2. b) Seafood Stuffing, Product Number: 4595. Recall # F-494-2. c) Seafood & Shrimp Salad, Product Number: 4314. Recall # F-495- 2. CODE a) Sell By date: 1/16/02-1/26/02; b) Sell by date: 1/16/02-2/9/02; c) Sell by date: 1/16/02-1/28/02. RECALLING FIRM/MANUFACTURER Silver Spoon Salad Co., Inc., Chelsea, MA, by telephone on January 16, 2002. Firm initiated recall is complete. REASON Undeclared crabmeat. VOLUME OF PRODUCT IN COMMERCE a) 745 lbs; b) 70 lbs; c) 50 lbs. DISTRIBUTION MA, RI and NH. _______________________ PRODUCT Truffle candies in boxes labeled in part "Moonstruck Chocolate Co." a) Truffle 9 Pack Classic Assortment (net wt. 4.5 oz.). Recall # F-496-2; b) Assorted Truffles Classic Collection 16 piece (net wt. 9 oz.). Recall # F-497-2; c) Assorted Truffles, Spring Collection, 12 piece (net wt. 6 oz.). Recall # F-498-2. CODE "best enjoyed by date" of up to and including "July 19, 2002" RECALLING FIRM/MANUFACTURER Moonstruck Chocolatier, Portland, OR, by letters on April 30, 2002. FDA initiated recall is complete. REASON Products contain undeclared egg whites & fd&c yellow #6. VOLUME OF PRODUCT IN COMMERCE a) 128 cs.; b) 174 cs.; c) 200 units. DISTRIBUTION CA, CT, IL, IN and OR. _______________________ PRODUCT Pastas listed below are packaged in transparent polypropylene bags attached to a cardboard labeling tag: Recall # F-501-2. 6 oz. individual bags of pasta including the following: Think Snow Pasta, net wt 6 oz (170g) Crazy for Tennis Pasta, net wt 6 oz (170g) Happy Birthday Pasta, net wt 6 oz (170g) Thinking of You Pasta, net wt 6 oz (170g) Star of David Pasta, net wt 6 oz (170g) Crazy for Golf Pasta, net wt 6 oz (170g) For a Special Mom Pasta, net wt 6 oz (170g) Dear Santa Pasta, net wt 6 oz (170g) The Night before Christmas Pasta, net wt 6 oz (170g) Lone Star Pasta, net wt 6 oz (170g) Get Well Soon Pasta, net wt 6 oz (170g) Love and Kisses Pasta, net wt 6 oz (170g) Soccer Pasta, net wt 6 oz (170g) Crazy for Fishin’ Pasta, net wt 6 oz (170g) Surfin’ the Net Pasta, net wt 6 oz (170g) Crazy for Racing Pasta, net wt 6 oz (170g) Good Luck Pasta, net wt 6 oz (170g) New York City Pasta, net wt 6 oz (170g) Memphis Blues Pasta, net wt 6 oz (170g) Crazy for Cats Pasta, net wt 6 oz (170g) Hippity Hop Pasta, net wt 6 oz (170g) Gourmet by the Pasta Shoppe Vinyard Pasta Grape Clusters & Leaves- Thanks a Million Pasta, net wt 6 oz (170g) My First Baby Pasta – My First Pasta net wt 6 oz (170g) Ghouly Ghost Pasta, net wt 6 oz (170g) Spooky Spider Pasta, net wt 6 oz (170g) Football Pasta, net wt 6 oz (170g) Music Pasta, net wt 6 oz (170g) Fall Festival Pasta, net wt 6 oz (170g) Heavenly Holiday Pasta, net wt 6 oz (170g) Crazy for Dogs Pasta, net wt 6 oz (170g) Home Sweet Home Pasta, net wt 6 oz (170g) Stars and Stripes Pasta, net wt 6 oz (170g) Cravin’ the Crab Pasta, net wt 6 oz (170g) Crazy for Sailing Pasta, net wt 6 oz (170g) Baseball Pasta, net wt 6 oz (170g) Crazy for Gardening Pasta, net wt 6 oz (170g) Trees Christmas Pasta, net wt 6 oz (170g) Snowman pasta, net wt 6 oz (170g) Bama Crimson Tide pasta, net wt 6 oz (170g) Auburn Tiners pasta, net wt 6 oz (170g) Bulldog Pasta, net wt 6 oz (170g) Jay Hawks KU Pasta, net wt 6 oz (170g) Wolverine Michigan Pasta, net wt 6 oz (170g) Spartan Pasta, net wt 6 oz (170g) Huskers Pasta, net wt 6 oz (170g) Tar Heel’s NC Pasta, net wt 6 oz (170g) Fightin’ Irish Pasta, net wt 6 oz (170g) Buckeye Pasta, net wt 6 oz (170g) Nittany Lion Pasta, net wt 6 oz (170g) Big Orange UT Pasta, net wt 6 oz (170g) Badger Pasta, net wt 6 oz (170g) Texas A&M Pasta, net wt 6 oz (170g) – this product was distributed unlabeled. These mixes listed below are packaged in transparent polypropylene bags with a cardboard overwrap label. Ready Set Chili, Quick Chili Mix with Boot Kicking Pasta in two varieties: Spicy Quick Chili Mix, net wt 7.75oz (219g). Recall # F-502-2; Southern Homestyle, net wt 7.75oz (219g). Recall # F-503-2; Ready Set Soup, in the following varieties: Chicken Noodle, net wt 9.75oz (275g). Recall # F-504-2; Garden Vegetable, Veggie Shaped Pasta with Soup Mix, net wt 8.5oz (241g). Recall # F-505-2; Homestyle Veggie, Home Sweet Home Pasta with Soup Mix, net wt 8.5oz (241g). Recall # F-506-2; Cowboy Black Bean, Boot and Wagon Pasta with Soup Mix, net wt 9oz (255g). Recall # F-507-2; Ready Set Salad in the following varieties: Team Sports Pasta with Sweet & Sour Vinaigrette, net wt 14oz (396g). Recall # F-508-2; Picnic Pasta with Ranch & Herb Dressing, net wt 12.75oz (361g). Recall # F-509-2; Garden Vegetable Pasta with Creamy Herb Dressing, net wt 12.75oz (361g). Recall # F-510-2; Team Pasta with Sweet & Sour Vinaigrette, net wt 14oz (396g). Recall # F-511-2; Golf Pasta with Ranch and Herb Dressing, net wt 12.75 oz (361g). Recall # F-512-2; Gingerbread Man Pasta with Sweet & Sour Vinaigrette, net wt 14oz (396g). Recall # F-513-2; Bushel of Apples Pasta with Apple Cider Vinaigrette, net wt 14oz (396g). Recall # F-514-2; Home Sweet Pasta with Sweet & Sour Vinaigrette, net wt 14oz (396g). Recall # F-515-2; Heart Pasta with Sweet & Sour Vinaigrette, net wt 14oz (396g). Recall # F-516-2; Million Dollar Pasta with Ranch & Herb Dressing, net wt 12.75 oz (361g). Recall # F-517-2; Vineyard pasta with Red Wine Vinaigrette, net wt 14oz (396g). Recall # F-518-2; Ready Set Meals in minutes in the following varieties: Sunshine & Flower Pasta Meal with Sunny Day Vinaigrette, net wt 14oz (397g). Recall # F-519-2; Fall Leaves Pasta with Classic Marinara Sauce Mix, net wt 13.2 oz (374g). Recall # F-520-2; Chicken Pasta Salad with Chicken Salad Seasoning Mix, net wt 8.85oz (248g). Recall # F-521-2. Musical Pasta Meal with Sweet Melody Vinaigrette, net wt 14oz (397g). Recall # F-522-2; Snowman & Snowflake Pasta with Creamy Parmesan Sauce Mix, net wt 12.75oz (361g). Recall # F-523-2; Trees & Santa Pasta with Classic marinara sauce mix, net wt 13.2oa (374g) – this product was distributed unlabeled. Recall # F-524-2; Easy Cheesy Pasta, in the following varieties: Team Sports, net wt 12oz (340g). Recall # F-525-2; Under the Sea, net wt 12oz (340g). Recall # F-526-2; Heart to Heart, net wt 12oz (340g). Recall # F-527-2; Down on the Farm, net wt 12oz (340g). Recall # F-528-2. CODE The individual products are not coded. Cases of product are coded. Codes involved are 0401N and 0402N. RECALLING FIRM/MANUFACTURER The Pasta Shoppe, LLC, Nashville, TN, by telephone on April 5, 2002 followed by fax and letter. Firm initiated recall is complete. REASON Undeclared egg whites in pasta. VOLUME OF PRODUCT IN COMMERCE 196,154 units. DISTRIBUTION Nationwide and Canada. _______________________ PRODUCT Berghaus Butterkase Cheese, 4-6oz. retail size units. Recall # F-538-2. CODE Sell by date 7/16/01. RECALLING FIRM/MANUFACTURER Recalling Firm: Schratter Foods Inc., Fairfield, NJ, by letters on May 4, 2001. Manufacturer: Bayernland AG Nurnberg, Germany. Firm initiated recall is complete. REASON The Department of Defense found the product to be contaminated with Salmonella. VOLUME OF PRODUCT IN COMMERCE 379 cases. DISTRIBUTION Nationwide. _______________________ PRODUCT Morey's Smoked Ciscoes Chubs in plastic trays wrapped in cellophane. The packages have individual net weights with a target weight of .75 lbs. In addition to the retail packages, described above, the recalled product was distributed in bulk in cases holding 5 pounds. Recall # F-539-2. CODE Lot number “3990” and “Not To Be Sold or Consumed After” date of “5/25/02.” RECALLING FIRM/MANUFACTURER Morey Fish Company, Motley, MN, by telephone on May 20, 2002. State initiated recall is ongoing. REASON The Michigan Department of Agriculture found the product to be contaminated with Listeria monocytogenes. VOLUME OF PRODUCT IN COMMERCE 1,169 pounds. DISTRIBUTION Nationwide. _______________________ PRODUCT The Jarritos brand Mexican Tamarind Paste Candy in Ceramic Pots. The product is packaged as 12 pots, each within a plastic bag, to a package. The only labeling is on the package. There are 20 packages to a case. Recall # F-540-2. CODE Product not coded. RECALLING FIRM/MANUFACTURER Recalling Firm: Villarreal Distributors dba Villarreal Distributing Co., San Antonio, TX, by letter dated July 25, 2001 and by fax on July 27, 2001. Manufacturer: La Barca II Dulceria, Jalisco, Mexico. FDA initiated recall is complete. REASON The product contained elevated levels of lead. VOLUME OF PRODUCT IN COMMERCE 90 cases of 20 x 12 pots for a total of 21,600 pots. DISTRIBUTION Nationwide.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II

_______________________ PRODUCT Caravelle Brand "BOT BANG" Tapioca Pearl, 14 ounce packages. Recall # F-499-2. Comes in two color schemes labeled identically but with different internal product number designations: TL 0466; Rosella & TL 0468; Mixed Colors. CODE All codes all lots. RECALLING FIRM/MANUFACTURER Anhing Corp., Los Angeles, CA, by letter on February 25, 2002. State initiated recall is complete. REASON The product contained the unapproved color additive carmoisine. VOLUME OF PRODUCT IN COMMERCE 150 cases. DISTRIBUTION Nationwide. _______________________ PRODUCT Salad dressings in 12 oz. glass jars and 32 oz. plastic jars with label affeixed to jars. Label states in part "Blake's Old Fashioned Dressing Ingredients: ** Mayonnaise** Keep Refrigerated ** a) THOUSAND ISLAND. Recall # F-529-2; b) BLEU CHEESE. Recall # F-530-2; c) RANCH. Recall # F-531-2. CODE MAY 28 2002, JUN 28 2002, JUL 28 2002, AUG 28 2002 Dates represent a 4 month pull date from date of manufacture. RECALLING FIRM/MANUFACTURER L & B Holdings dba Blake's Old Fashioned Dressing, Bonners Ferry, ID, by telephone on May 8, 2002. FDA initiated recall is complete. REASON The products fail to list the subingredients of ingredients such as mayonnaise, buttermilk, bleu cheese, and yogurt. VOLUME OF PRODUCT IN COMMERCE 106 units. DISTRIBUTION ID. _______________________ PRODUCT a) Cranberry Nut Bagels. Recall # F-532-2; b) Cheese Bagels. Recall # F-533-2; c) Asiago Bagels. Recall # F-534-2; d) Cherry Almond Bagels. Recall # F-535-2. CODE None, product manufactured prior to 4/16/02. RECALLING FIRM/MANUFACTURER The Bagel Factory, Ann Arbor, MI, by telephone and fax on April 16 and 17, 2002. Firm initiated recall is complete. REASON All products contained undeclared FD&C Yellow No. 5 and Yellow No. 6. Cherry Almond Bagels also contained undeclared Red No. 3. VOLUME OF PRODUCT IN COMMERCE Undetermined. DISTRIBUTION MI. _______________________ PRODUCT Ocean King Brand Cajan Krab Dip. The product is sold is 5 lb. plastic containers. The product is a seafood dip. Recall # F-537-2. CODE Sell thru 8/4/01. RECALLING FIRM/MANUFACTURER Ocean King Enterprises, Inc., Folcroft, PA, by telephone on September 30, 2001. State initiated recall is complete. REASON Undeclared FD&C Yellow #5, Red #40 and Blue #1. VOLUME OF PRODUCT IN COMMERCE 50 containers. DISTRIBUTION NY.

RECALLS AND FIELD CORRECTIOS: FOODS -- CLASS III

_______________________ PRODUCT Diet Coke in 12 oz. aluminum cans. Recall # F-480-2. CODE May0602LXA 05:00 - 10:00. RECALLING FIRM/MANUFACTURER Recalling Firm: Coca-Cola Enterprises, Inc., Atlanta, GA, by letter and visits on February 28, 2002. Manufacturer: Coca-Cola Bottling Company of Mid-America, Lenexa, KS. Firm initiated recall is complete. REASON The product was contaminated with ammonia. VOLUME OF PRODUCT IN COMMERCE 5,950 cases. DISTRIBUTION KA, MO and NE. _______________________ PRODUCT Heart Loc Yellow Food Color (Egg Shade) packaged in 32-fl. oz. (1 qt.) plastic containers, 6 containers per carton. Recall # F-536-2. CODE Product produced between 1/6/00 (0A06) through 1/15/02 (2A15). RECALLING FIRM/MANUFACTURER Recalling Firm: Tones Spices, Inc., Ankeny, IA, by telephone beginning March 5, 2002. Manufacturer: Shanks Extracts, Inc., Lancaster, PA. FDA initiated recall is complete. REASON Mislabeled as containing Red #4 instead of Red #40. VOLUME OF PRODUCT IN COMMERCE 32,604 bottles DISTRIBUTION Nationwide.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II

_______________________ PRODUCT Lomotil Tablets (diphenoxylate hydrochloride, USP 2.5 mg and atropine sulfate, USP 0.025 mg), 100 tablets, Rx only. Recall # D-334-2. CODE Lot Number: 021245, Exp. Date Apr 17 04. RECALLING FIRM/MANUFACTURER Recalling Firm: AmeriSource Health Services Corp., Columbus, OH, by letter and fax on June 10, 2002. Manufacturer: G.D. Searle & Company, Chicago, IL. Firm initiated recall is ongoing. REASON Tablets supplied by the manufacturer may contain metal particles. VOLUME OF PRODUCT IN COMMERCE 1,288 bottles of 100 tablets each. DISTRIBUTION Nationwide.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III

______________________ PRODUCT Calcijex, Calcitriol Injection, For I.V. use, 1 mcg/mL single dose ampul, Rx Only. Recall # D-230-2. CODE Lot No. 85-305-DK, Exp Date May 1, 2003 NDC 0074-8110-31 THIS RECALL IS BEING EXTENDED ON MAY 16, 2002 TO INCLUDE ONE ADDITIONAL LOT: Lot No. 85-261-DK, Exp Date May 1, 2003 NDC 0074-8110-31. RECALLING FIRM/MANUFACTURER Recalling Firm: Abbott Laboratories, Abbott Park, IL, by letter on March 7, 2002. Manufacturer: Abott Laboratories, Rocky Mount, NC. Firm initiated recall is ongoing. REASON Mispackaging: Vitamin K1 Injection found in a box of Calcijex injection. VOLUME OF PRODUCT IN COMMERCE 126,075 units. DISTRIBUTION Nationwide. _______________________ PRODUCT Various tablet, liquid and capsule dosage form drug products, repackaged into bottles and unit dose blister packs of varying sizes/counts, labeled with brand or generic names, strength, lot number, expiration date, National Drug Codes (NDC)and packager identified as TYA Pharmaceuticals AGENERASE Capsules 150 mg blister packs. Recall # D-289-2; AMITRIPTYLINE HCl Tablets 50 mg QTY 30/300. Recall # D-290-2; *ASPIRIN ENETERIC COATED 5 GR QTY 30/300. Recall # D-291-2; CHLORPROMAZINE Liquid 300 mg 3 mL bottles. Recall # D-292-2; CLONIDINE HCl Tablet 0.3 mg QTY 30/300. Recall # D-293-2; DIPHENHYDRAMINE Liquid 50 mg 20 mL bottles. Recall # D-294-2; DIPHENHYDRAMINE Liquid 75 mg 30 mL bottles. Recall # D-295-2; DOXEPIN Liquid 50 mg 5 mL bottles. Recall # D-296-2; DOXEPIN Liquid 100 mg 10 mL bottles. Recall # D-297-2; DOXEPIN Liquid 150 mg 15 mL bottles. Recall # D-298-2; DOXEPIN Liquid 200 mg 20 mL bottles. Recall # D-299-2; ENALAPRIL Tablets 10 mg QTY 30/400. Recall # D-300-2; FLUPHENAZINE Liquid 5 mg 1 mL bottles. Recall # D-301-2; FLUPHENAZINE Liquid 10 mg 2 mL bottles. Recall # D-302-2; FLUPHENAZINE Liquid 20 mg 4 mL bottles. Recall # D-303-2; GLYBURIDE Tablet 2.5 mg QTY 30/200. Recall # D-304-2; HALOPERIDOL Liquid 2 mg 1 mL bottles. Recall # D-305-2; HALOPERIDOL Liquid 5 mg 2.5 mL bottles. Recall # D-306-2; HALOPERIDOL Liquid 10 mg 5 mL bottles. Recall # D-307-2; HALOPERIDOL Liquid 15 mg 7.5 mL bottles. Recall # D-308-2; HALOPERIDOL Liquid 20 mg 10 mL bottles. Recall # D-309-2; HIVID Tablets .75 mg. Recall # D-310-2; HYDROXYZINE HCl Liquid 25 mg 12.5 mL bottles. Recall # D-311-2; HYDROXYZINE HCl Liquid 50 mg 25 mL bottles. Recall # D-312-2; LITHIUM CARBONATE Capsules 300 mg QTY 30/300. Recall # D-313-2; LITHIUM Liquid 300 mg 5 mL bottles. Recall # D-314-2; LITHIUM Liquid 450 mg 7.5 mL bottles. Recall # D-315-2; LITHIUM Liquid 600 mg 10 mL bottles. Recall # D-316-2; LITHIUM Liquid 1200 mg 20 mL bottles. Recall # D-317-2; RANITIDINE USP Tablets 150 mg QTY 30/300. Recall # D-318-2; SUSTIVA Capsules 200 mg blister packs. Recall # D-319-2; THIORIDAZINE Liquid 75 mg .75 mL bottles. Recall # D-320-2; THIORIDAZINE Liquid 100 mg 1 mL bottles. Recall # D-321-2; THIORIDAZINE Liquid 200 mg 2 mL bottles. Recall # D-322-2; TRIAMTERENE HCTZ Capsules 50/25 mg QTY 30/300. Recall # D-323- 2; VALPROIC ACID Liquid 500 mg 10 mL bottles. Recall # D-324-2; VALPROIC ACID Liquid 1000 mg 20 mL bottles. Recall # D-325-2; ZERIT Capsules 30 mg blister packs. Recall # D-326-2; ZERIT Capsules 40 mg blister packs. Recall # D-327-2; ZITHROMAX Tablets 600 mg blister packs. Recall # D-328-2; CHLORPROMAZINE Liquid 100 mg 1 mL bottles. Recall # D-333-2 *Enteric is misspelled on product label. CODE AGENERASE Capsules 150 mg blister packs--------Lot# 00382C AMITRIPTYLINE HCl Tablets 50 mg QTY 30/300-----Lot# 001081A ASPIRIN ENETERIC COATED 5 GR QTY 30/300--------Lot# 1539 CHLORPROMAZINE Liquid 300 mg 3 mL bottles------Lot# 156294A CLONIDINE HCl Tablet 0.3 mg QTY 30/300---------Lot# 1J2840 DIPHENHYDRAMINE Liquid 50 mg 20 mL bottles-----Lot# 2607A DIPHENHYDRAMINE Liquid 75 mg 30 mL bottles-----Lot# 2607A DOXEPIN Liquid 50 mg 5 mL bottles--------------Lot# 2678A DOXEPIN Liquid 100 mg 10 mL bottles------------Lot# 2678A DOXEPIN Liquid 150 mg 15 mL bottles------------Lot# 2678A DOXEPIN Liquid 200 mg 20 mL bottles------------Lot# 2678A ENALAPRIL Tablets 10 mg QTY 30/400-------------Lot# CHO0987, 1170205 FLUPHENAZINE Liquid 5 mg 1 mL bottles----------Lot# MFC06 FLUPHENAZINE Liquid 10 mg 2 mL bottles---------Lot# MFC06 FLUPHENAZINE Liquid 20 mg 4 mL bottles---------Lot# MFC06 GLYBURIDE Tablet 2.5 mg QTY 30/200-------------Lot# 124884A HALOPERIDOL Liquid 2 mg 1 mL bottles-----------Lot# 2505A, 2505D HALOPERIDOL Liquid 5 mg 2.5 mL bottles---------Lot# 2505A, 2505D HALOPERIDOL Liquid 10 mg 5 mL bottles----------Lot# 2505A, 2505D HALOPERIDOL Liquid 15 mg 7.5 mL bottles--------Lot# 2505A, 2505D HALOPERIDOL Liquid 20 mg 10 mL bottles---------Lot# 2505A, 2505D HIVID .75mg-----------------------------------Lot# 47117A, 40558A HYDROXYZINE HCl Liquid 25 mg 12.5 mL bottles---Lot# 24303C HYDROXYZINE HCl Liquid 50 mg 25 mL bottles-----Lot# 24303C LITHIUM CARBONATE Capsules 300 mg QTY 30/300---Lot# 111077A LITHIUM CITRATE Liquid 300 mg 5 mL bottles-----Lot# 158273A, 158274A LITHIUM CITRATE Liquid 450 mg 7.5 mL bottles---Lot# 158273A, 158274A LITHIUM CITRATE Liquid 600 mg 10 mL bottles----Lot# 158273A, 158274A LITHIUM CITRATE Liquid 1200 mg 20 mL bottles---Lot# 158273A, 158274A RANITIDINE USP Tablets 150 mg QTY 30/300-------Lot# 00382C SUSTIVA Capsules 200 mg blister packs----------Lot# EPK347A, EPK372A, EPK373A THIORIDAZINE Liquid 75 mg .75 mL bottles-------Lot# 156303A THIORIDAZINE Liquid 100 mg 1 mL bottles--------Lot# 156303A THIORIDAZINE Liquid 200 mg 2 mL bottles--------Lot# 156303A TRIAMTERENE HCTZ Capsules 50/25 mg QTY 30/300--Lot# 101901A VALPROIC ACID Liquid 500 mg 10 mL bottles------Lot# 14010 VALPROIC ACID Liquid 1000 mg 20 mL bottles-----Lot# 14010 ZERIT Capsules 30 mg blister packs-------------Lot# 1C50244 ZERIT Capsules 40 mg blister packs-------------Lot# 1G52495 ZITHROMAX Tablets 600 mg blister packs---------Lot# 009K01E CHLORPROMAZINE Liquid 100 mg 1mL bottles-------Lot# 156294A. RECALLING FIRM/MANUFACTURER TYA Pharmaceuticals, Tallahassee, FL, by telephone and letter on February 27, 2002. Firm initiated recall is ongoing. REASON Labeled with incorrect expiration date. VOLUME OF PRODUCT IN COMMERCE 277,750 doses. DISTRIBUTION TX and FL.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

_______________________ PRODUCT Source Plasma, Recall # B-1282-2. CODE Units DFFJXD, DFFKMJ, DFFLDH, DFFPJF, DFGG. RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc., Tempe, AZ, by fax dated October 15, 2001. Firm initiated recall is complete. REASON Blood products, collected from a donor with a history of incarceration within the past 12 months, were distributed. VOLUME OF PRODUCT IN COMMERCE 5 units. DISTRIBUTION IL.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

_______________________ PRODUCT Red Blood Cells, Recall # B-1257-2. CODE Units N36211, N36215, 36220. RECALLING FIRM/MANUFACTURER Penn State, Milton S. Hershey Medical Center, Hershey, PA, by letter dated December 6, 2001. Firm initiated recall is complete. REASON Blood products, incorrectly tested for antibody to hepatitis C virus (anti-HCV), were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION PA. _______________________ PRODUCT a) Red Blood Cells, Recall # B-1259-2; b) Platelets, Recall # B-1260-2. CODE a) Units N70531, N70539, N70540; b) Units N70529, N70533, N70539, N70534. RECALLING FIRM/MANUFACTURER Penn State, Milton S. Hershey Medical Center, Hershey, PA, by letters dated October 26, November 5, 2001 and November 6, 2001. Firm initiated recall is complete. REASON Blood products, incorrectly tested for antibody to the human T- lymphotropic virus type I/II (anti-HTLV-I/II), were distributed. VOLUME OF PRODUCT IN COMMERCE 7 units. DISTRIBUTION PA. _______________________ PRODUCT Two Unit Red Cell Disposable Set with Leukoreduction Filter, Recall # B-1446-2. CODE Lot numbers H01129, H01226, L01052, K01131, L01027, UU01136, VV01115, VV01119, XX01237, YY01127, YY01179, YY01183, YY01189, ZZ01096, ZZ01104, NN02004, and NN02136. RECALLING FIRM/MANUFACTURER Haemonetics Corporation, Raintree, MA, by telephone and fax on April 12 and 15, 2002. Firm initiated recall is complete. REASON Red blood cell collection sets, that included a leukoreduction filter that may not adequately remove white blood cells, were distributed. VOLUME OF PRODUCT IN COMMERCE 17 lots. DISTRIBUTION AZ, NJ, IA, IN, FL, Austria, Belgium and Sweden.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

_______________________ PRODUCT STERRAD 100S Sterilization System. Recall # Z-1082-2. CODE Version 3 or lower is subject to upgrade. Newer versions contain software "fix". Current version is Version 6. RECALLING FIRM/MANUFACTURER Advanced Sterilization Products, Irvine, CA, by letters sent March 28, 2002. Firm initiated recall is ongoing. REASON Software anomaly allows half cycle run when full cycle displayed. VOLUME OF PRODUCT IN COMMERCE 1,405 DISTRIBUTION Nationwide. _______________________ PRODUCT Interplak power plaque remover toothbrush, battery operated toothbrush used to brush teeth and remove plaque. Recall # Z-1104-2. CODE Model number 12209W. RECALLING FIRM/MANUFACTURER Recalling Firm: Conair Corp., East Windsor, NJ, by telephone approximately March 28, 2002. Manufacturer: Gimelli Laboratories Co. Ltd., Shenzen Bao'An, Guangdong. Firm intiated recall is ongoing. REASON Batteries leaking hydrogen gas during charging popping off the end cap. VOLUME OF PRODUCT IN COMMERCE 15,758 units. DISTRIBUTION Nationwide.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III

_______________________ PRODUCT Invacare IRC 2121 Select Flow, CGS 870, 0-6L medical oxygen regulators. Recall # Z-1103-2. CODE Serial numbers 0203 00322 through 0203 00496. RECALLING FIRM/MANUFACTURER Essex Industries, Inc., St. Louis, MO, by fax on February 22, March 26 and April 11, 2002. Firm initiated recall is ongoing. REASON Mislabeled as 0-6 LPM rather than 0-8 LPM. VOLUME OF PRODUCT IN COMMERCE 175 regulators. DISTRIBUTION IN.

END OF ENFORCEMENT REPORT FOR JUNE 19, 2002

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