April 2, 2003
03-14
_____________________________
PRODUCT
Asian Boy (EM BE QUE) brand Frozen Steamed Mackerel (CA BAC MA HAP), Net Weight: WEIGHT TO BE SOLD, KEEP FROZEN UNDER - 18 C (0 F). Product of Vietnam. Barcode #935026 010899. Recall # F-290-3.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Recalling Firm: BCN Trading Inc., Brooklyn, NY, by press release on July 19, 2002 and by letter dated July 22, 2002.
Manufacturer: Seafood Joint Stock Company No. 4 (Seapriexco No. 4), Ho Chi Minh City, SR Vietnam. State initiated recall is complete.
REASON
Uneviscerated processed fish.
VOLUME OF PRODUCT IN COMMERCE
45 cases (50 packages per case).
DISTRIBUTION
NY, NJ, CT, MA, PA,VA, MD, and FL.
_____________________________
PRODUCT
Golden Boy Frozen Cooked Mackerel Fish (CA BAC MA HAP), Packed for L.H.F. Trading Co. USA, Product of Vietnam, UPC 88183-06017 - three fish in basket; UPC 88183-06008 - two fish in basket. Recall # F-291-3.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Lien Hoa Food Corp., Chicago, IL, by letters dated October 4, 2002. State initiated
recall is complete.
REASON
Uneviscerated processed fish.
VOLUME OF PRODUCT IN COMMERCE
50 cases.
DISTRIBUTION
IL, IN, MI, MN, OH, WI, NY.
_____________________________
PRODUCT
Goldup brand Aam Papad Dry Mango Slices, wt. 150 gms./5.25 ozs. Product of India. Product is packed in flexible plastic bags. Recall # F-292-3.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Pexco, Inc., Maspeth, NY, by letter and Allergen Alert on April 17, 2002. State initiated recall is complete.
REASON
The product contained undeclared sulfites.
VOLUME OF PRODUCT IN COMMERCE
120 units.
DISTRIBUTION
NY, NJ, CT, MD.
_____________________________
PRODUCT
Kirsch (TM) Sun-Dried Tomatoes, Net wt. 3 oz. (84 g). packaged in rigid plastic containers. Ingredients: Sun Dried Tomatoes. Barcode # 72291 18000. Recall # F-293-3.
CODE
"Best if Used By Nov 1 2001".
RECALLING FIRM/MANUFACTURER
Kirsch Mushroom Co., Inc., Bronx, NY, by e-mail on April 16, 2001 and Allergen Alert on May 14, 2001. State initiated recall is complete.
REASON
The product contained undeclared sulfites.
VOLUME OF PRODUCT IN COMMERCE
783 - 3 oz. packages.
DISTRIBUTION
NY and NJ.
_____________________________
PRODUCT
a) Farm Raised Salmon Pinwheel Lobster Stuffing.
Recall # F-297-3;
b) Ready to Eat Lobster Stuffing. Recall # F-298-3.
CODE
Pack Dates January 7 through January 16..
RECALLING FIRM/MANUFACTURER
Ocean King Enterprises, Inc., Folcroft, PA, by press release on January 15, 2002, and January 16, 2002 and by letters. FDA initiated recall is complete.
REASON
The products contain undeclared ingredients, including soy protein and subingredients of mayonnaise.
VOLUME OF PRODUCT IN COMMERCE
1000 lbs.
DISTRIBUTION
PA, NJ, CT, DE, MA, NY, and RI.
_____________________________
PRODUCT
a) Farm Raised Salmon Pinwheel Shrimp Florentine Stuffing.
Recall # F-299-3;
b) Ready to Eat Shrimp Florentine Stuffing.
Recall # F-300-3.
CODE
Pack Dates January 7 through January 16..
RECALLING FIRM/MANUFACTURER
Ocean King Enterprises, Inc., Folcroft, PA, by press release on January 15, 2002, and January 16, 2002 and by letters. FDA initiated recall is complete.
REASON
The products contain undeclared ingredients, including the subingredients of mayonnaise.
VOLUME OF PRODUCT IN COMMERCE
1000 lbs.
DISTRIBUTION
PA, NJ, CT, DE, MA, NY, and RI.
_____________________________
PRODUCT
Cookies, biscotti, and cinnamon rolls. Cookies are sold in individual polypropylene bags shipped in either 12, 20, or 24 cookies/bag. The cookies come in a gift box, tin, or glass jar. No labels.
Cookies include:
a) Chocolate Chip. Recall # F-305-3;
b) Bigfoot. Recall # F-306-3;
c) Oatmeal raisin. Recall # F-307-3;
d) Peanut Butter. Recall # F-308-3;
e) Peanut Butter Chocolate Chip. Recall # F-309-3;
f) Snickerdoodle. Recall # F-310-3;
g) Java Jumble. Recall # F-311-3;
h) Cadillac. Recall # F-312-3;
i) Ginger. Recall # F-313-3;
j) Biscotti. Recall # F-314-3;
k) Cinnamon Rolls. Recall # F-315-3.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Brookies Cookies, Bigfork, MT, by visit on September 17 and 18, 2002, and by letter dated September 19, 2002. FDA initiated recall is complete.
REASON
The products do not bear necessary ingredient statements and contain allergens such as eggs, milk, peanuts, tree nuts and wheat.
VOLUME OF PRODUCT IN COMMERCE
212 cookies.
DISTRIBUTION
MT.
_____________________________
PRODUCT
3- gallon containers of ice cream labeled as
follows: "TODAY**TODAYS FROZEN DESERTS INC. 3 GAL.,
There is also a handwritten flavor or style name on the container. Flavors may include:Premium Vanilla Mix, Premium Chocolate Mix, Banana Nut, Black Cherry, Bubblegum, Butter Pecan, Cappuchino Flake, Chocolate, Chocolate Flake, Chocolate Peanut Butter Swirl, Chunky Monkey, Cinnamon, Coconut, Coffee, Cookie Do, Cookies N Cream, Dulce de Leche, Egg Nog, French Vanilla, Grapenut, Grapenut Special, Heath Bar, Kaluha Almond Fudge, Kola Champagne, Mango, Maple Walnut, Mint Flake, Mudd Pie, New York Cherry, Orange Pineapple, Peanut Butter Fudge, Pina Colada, Pistachio, Pistachio Grapenut, Praline, Rocky Road, Rum Nut, Rum Raisin, Snickers, Sour Sop (Guanabana), Strawberry Cheesecake, Stout, Strawberry, Vanilla Bean, Vanilla Black Cherry, Vanilla Brownie Fudge, Vanilla Flake, and Vanilla Fudge. Recall # F-316-3.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Today's Frozen Desserts, Inc., Miami, FL, by Ingredient informational sheets on March 21, 2002. FDA initiated recall is complete.
REASON
The products do not bear required ingredient statements and contain ingredients such as peanuts, tree nuts, and FD&C Yellow No.5.
VOLUME OF PRODUCT IN COMMERCE
Approx. 5000 3 gallons.
DISTRIBUTION
FL.
_____________________________
PRODUCT
Diamond Bakery brand Baklava 12 oz. and 27 oz. packages. The baklava is in paper cups, packaged in a tin foil tray with a plastic covering, and shrink wrapped. Recall # F-317-3.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Diamond Bakery, Burlingame, CA, by in-person visits on July 24, 2002. Firm initiated recall is complete.
REASON
The product contained undeclared Acid Brilliant Green BS (nonpermitted color) and Tartrazine (certifiable as FD&C Yellow No 5.)
VOLUME OF PRODUCT IN COMMERCE
35.
DISTRIBUTION
CA.
_____________________________
PRODUCT
a) Milk chocolate topped sugar cookies packaged in clear
cellophane. Recall # F-320-3;
b) Dark chocolate topped sugar cookies packaged in clear
cellophane, 72 cookies/case. Recall # F-321-3;
c) Milk chocolate candy (bars, stars, coins, CDs, etc),
packaged in a variety of packages depending on product,
foil, plastic case, cellophane, plastic bag. The amount
of product/case is dependant on the product: anywhere
from 48 pieces to 600 pieces per case. Recall # F-322-3;
d) Sailboat shape white/dark chocolate, packaged in plastic
40 /case. Recall # F-323-3.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Totally Chocolate, Blaine, WA, by letter dated September 13, 2002. FDA initiated recall is complete.
REASON
Products do not bear any ingredient statement and contain allergenic ingredients.
VOLUME OF PRODUCT IN COMMERCE
507 cases.
DISTRIBUTION
To be determined.
_____________________________
PRODUCT
a) Ready to Eat Crab Stuffing. Recall # F-301-3;
b) Farm Raised Salmon Pinwheel Crab Stuffing.
Recall # F-302-3;
c) Farm Raised Salmon Pinwheel Crab Florentine Stuffing.
Recall # F-303-3;
d) Ready to Eat Crab Florentine Stuffing.
Recall # F-304-3.
CODE
Pack Dates January 7 through January 16.
RECALLING FIRM/MANUFACTURER
Ocean King Enterprises, Inc., Folcroft, PA, by press release on January 15, 2002, and January 16, 2002 and by letters. FDA initiated recall is complete.
REASON
The products do not bear complete ingredient statements.
VOLUME OF PRODUCT IN COMMERCE
1000 lbs.
DISTRIBUTION
PA, NJ, CT, DE, MA, NY, and RI.
_____________________________
PRODUCT
Lanoxin (digoxin) Elixir Pediatric, 50 mcg (0.05 mg), 60 ml bottle, Rx only. Recall # D-187-3.
CODE
Lot numbers: 1G605, 1F716, 1G608, 1H622, 1K618, 2D604, 2G704, and 2H602.
RECALLING FIRM/MANUFACTURER
Recalling Firm: SmithKline Beecham Corp., Zebulon, NC, by letters on/about February 11, 2003.
Manufacturer: Glaxo Wellcome, Research Triangle Park, NC. Firm initiated recall is ongoing.
REASON
Product contains brown cardboard particles.
VOLUME OF PRODUCT IN COMMERCE
282,850 units.
DISTRIBUTION
Nationwide.
_____________________________
PRODUCT
Terazosin Hydrochloride Capsules, 1 mg, 500 count bottles, Rx only. Recall # D-191-3.
CODE
Lot number 4336-707 Exp. Date Jun 03.
RECALLING FIRM/MANUFACTURER
Recalling Firm: IVAX Pharmaceuticals, Miami, FL, by letters on February 11, 2003.
Manufacturer: Zenith Goldline Pharmaceuticals, Inc. Firm initiated recall is ongoing.
REASON
Dissolution Failure; 18 month timepoint (stability).
VOLUME OF PRODUCT IN COMMERCE
50 bottles.
DISTRIBUTION
Nationwide.
_____________________________
PRODUCT
a) Acyclovir Tablets, USP, 400 mg, 100 tablet bottles,
Rx only. Recall # D-192-3;
b) Metformin Hydrochloride Tablets, 1000 mg, 500 tablet
bottles, Rx only. Recall # D-193-3;
CODE
a) Lot 553C21 Exp. 4/04;
b) Lot 438F21 Exp. 7/04.
RECALLING FIRM/MANUFACTURER
Alpharma Purepac, Elizabeth, NJ, by letter on February 5, 2003. Firm initiated recall is ongoing.
REASON
a) Tablets contain fibers;
b) Product may contain iron/zinc particles.
VOLUME OF PRODUCT IN COMMERCE
a) 16,482 bottles;
b) 1,970 bottles.
DISTRIBUTION
Nationwide.
_____________________________
PRODUCT
MD-Gastroview, (Diatrizoate Meglumine 660mg and Diatrizoate Sodium 100mg, Injection,
USP), 120mL amber glass, screw cap bottles, 367mg/mL Organically Bound Iodine,
Rx only. For Gastrointestinal radiography, Not For Parenteral Use. Recall #
D-179-3.
CODE
Lot numbers E009A and E026A.
RECALLING FIRM/MANUFACTURER
Tyco Healthcare, Raleigh, NC, by letter on February 24, 2003. Firm initiated recall is ongoing.
REASON
Misbranded; incorrectly labeled Diatrizoate Meglumine, Diatrizoate Sodium Injection rather than Diatrizoate Meglumine, Diatrizoate Sodium Solution.
VOLUME OF PRODUCT IN COMMERCE
3138 cases of lot E009A;
3134 cases of lot E026A.
DISTRIBUTION
Nationwide, Argentina and Costa Rica.
____________________________
PRODUCT
Oleic Acid, NF/FCC, (Clear), Class IIIB, 500 mL bottles. Recall # D-186-3.
CODE
Lot Number 022851.
RECALLING FIRM/MANUFACTURER
Fisher Scientific Group, Somerville, NJ, by letter on January 31, 2003. Firm initiated recall is ongoing.
REASON
Contamination; product contains yeast.
VOLUME OF PRODUCT IN COMMERCE
400 bottles.
DISTRIBUTION
Nationwide.
_____________________________
PRODUCT
Strattera Capsules (atomoxetine HC1) 40mg, 24 count bottle, Rx only, Adult Sample Pack. Recall # D-188-3.
CODE
6AE95B.
RECALLING FIRM/MANUFACTURER
Eli Lilly and Company, Indianapolis, IN, by fax on January 10, 2003. Firm initiated recall is ongoing.
REASON
Misbranded; bottle label is incorrectly printed as "First use blister".
VOLUME OF PRODUCT IN COMMERCE
89,360 bottles.
DISTRIBUTION
Nationwide.
_____________________________
PRODUCT
Doryx Capsules (coated doxycycline hyclate pellets) 75mg, 6 blisterpack physician samples (2 tablets each) and 60 count bottles, Rx only. Recall # D-189-3.
CODE
Lot numbers: 60 tablet bottles 60722662 Exp. 10/03;
60722690 Exp. 10/03; 60722663 Exp. 10/03.
Lot numbers: Physician Samples unit dose (Blisters)
60725446 Exp. 10/03; 60725446A Exp. 10/03;
60735786 Exp. 12/03; 60735786A Exp. 12/03;
1896 Exp. 3/03.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Warner Chilcott Labs, Rockaway, NJ, by letter on November 21, 2002.
Manufacturer: Faulding Pharmaceutical/DBL, a division of F. H. Faulding & Co., Limited, Salisbury, South Australia. Firm initiated recall is ongoing.
REASON
Lack of assurance of stability throughout labeled expiration.
VOLUME OF PRODUCT IN COMMERCE
51,858 bottles; 174,541 blisters.
DISTRIBUTION
Nationwide.
_____________________________
PRODUCT
Drituss GP Tablets, (Guaifenesin 1200mg and Pseudoephedrine hydrochloride 120mg) 100 count bottles, Long-Acting, Dye-Free, Rx only. Recall # D-190-3.
CODE
Lot numbers: 025L2A, 023L2A, 024L2A, 016B2RA, 015B2A, 003L1A, 010F2A.
RECALLING FIRM/MANUFACTURER
Vintage Pharmaceuticals LLC, Huntsville, AL, by letters on February 25, 2003. Firm initiated recall is ongoing.
REASON
Failure to validate manufacturing process.
VOLUME OF PRODUCT IN COMMERCE
18,499 bottles of 100 tablets.
DISTRIBUTION
Nationwide.
_____________________________
PRODUCT
Diltiazem CD Capsules (Diltiazem hydrochloride Extended-Release Capsules, USP)
180 mg, 90 capsule bottles, (Once-a-Day Dosage), Rx only. Recall # D-194-3;
CODE
Lot 725D21 Exp 3/04;
Lot 726D21 Exp 3/04;
Lot 727D31 Exp 3/04;
Lot 728D21 Exp 1/04.
RECALLING FIRM/MANUFACTURER
Alpharma Purepac, Elizabeth, NJ, by letter on February 5, 2003. Firm initiated recall is ongoing.
REASON
Failure to validate a reduced batch size manufacturing process.
VOLUME OF PRODUCT IN COMMERCE
33,005 bottles.
DISTRIBUTION
Nationwide.
_____________________________
PRODUCT
Kytril Tablets (granisetron HC1), 1mg, 2 tablet unit of use package and 20 tablet single unit package, Rx only. Recall # D-195-3.
CODE
Blister of 20 tablets: Lot numbers 029055 Exp. 4/2003;
029056 Exp. 4/2003; 036198 Exp. 3/2005; 036199 exp. 3/2005;
036200 Exp. 3/2005; 039142 Exp. 7/2005;
Blister of 2 tablets: Lot number 028107 Exp. 4/2003.
RECALLING FIRM/MANUFACTURER
Hoffmann LaRoche, Inc., Nutley, NJ, by letters on February 28, 2003. Firm initiated recall is ongoing.
REASON
Mispackaged; blistercard incorrectly contains two tablets rather than one tablet.
VOLUME OF PRODUCT IN COMMERCE
64,073 packages.
DISTRIBUTION
Nationwide.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0646-3;
b) Red Blood Cells. Recall B-0467-3;
c) Fresh Frozen Plasma. Recall # B-0648-3.
CODE
a) Units 12H53702, 12P12135, 12P22669, 12Z36587;
b) Unit 12C17518;
c) Units 12P22669, 12Q42637.
RECALLING FIRM/MANUFACTURER
American Red Cross, Carolinas Blood Services Region, Charlotte, NC, by letters
dated August 8, 2002, September 6, 2002 and September 9, 2002. Firm initiated
recall is complete.
REASON
Blood products, collected from a donor who was taking the medication Arava,
were distributed.
VOLUME OF PRODUCT IN COMMERCE
a) 4 unit;
b) 1 units;
c) 2 units.
DISTRIBUTION
TN, GA, NC, CA, NY, and Switzerland.
_____________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0690-3.
CODE
Unit number 04FS44187.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, New England Region, by letter dated November 13, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MA.
_____________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall #B-0691-3.
CODE
Unit number 04W28393.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, New England Region, Dedham, MA, by letter dated November 13, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
VT.
_____________________________
PRODUCT
Red Blood Cells. Recall # B-0705-3.
CODE
Unit number 71C64414-4.
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Gainesville, FL, by telephone on December 12, 2001. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
FL.
_____________________________
PRODUCT
Red Blood Cells. Recall # B-0706-3.
CODE
Unit number 04V34102-5.
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Gainesville, FL, by facsimile on August 17, 2001. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
FL.
_____________________________
PRODUCT
Platelets Pheresis. Recall # B-0712-3.
CODE
Unit number 084C24862.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Northern California Region, Oakland, CA, by letter on March 27, 2000. Firm initiated recall is complete.
REASON
Blood product, for which documentation of irradiation was incomplete, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.
_____________________________
PRODUCT
Source Plasma (For manufacturing Use Only).
Recall # B-0715-3.
CODE
Unit 00SWIB3076.
RECALLING FIRM/MANUFACTURER
Community Bio-Resources, Inc., Sheboygan, WI, by fax dated July 27, 2000. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who had not completed the CJD/nvCJD increased risk questions, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Austria.
_____________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced Irradiated. Recall # B-0716-3.
CODE
Unit number 53FC16702.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Greater Chesapeake and Potomac Region, Baltimore, MD, by letter dated September 6, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MD.
_____________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0717-3.
CODE
Unit number 29FL64335.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Mid-Atlantic Region, Norfolk, VA, by letter dated April 26, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NC.
_____________________________
PRODUCT
Platelets Pheresis. Recall # B-0718-3.
CODE
Unit number 29FL64335.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Mid-Atlantic Region, Norfolk, VA, by letter dated January 14, 2003. Firm initiated recall is complete.
REASON
Blood product, collected using a phlebotomy method that may have compromised the sterlity of the products, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NC.
_____________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0719-3;
b) Recovered Plasma. Recall # B-0720-3.
CODE
a) and b) Unit number 29GP68691.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Mid-Atlantic Region, Norfolk, VA, by letters on April 29, 2002, and May 6, 2002.
Firm initiated recall is complete.
REASON
Blood products tested negative for viral markers but were collected from an ineligible donor due to a risk factor for increased incidence of infection with human immunodeficiency virus (HIV).
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
NC and CA.
_____________________________
PRODUCT
Red Blood Cells. Recall # B-0723-3.
CODE
Unit number KS08789.
RECALLING FIRM/MANUFACTURER
Inova Health Care Services, Blood Donor Services, Annandale, VA, by facsimile on July 3, 2002. Firm initiated recall is complete.
REASON
Blood product collected from a donor that did not answer one of the history questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV).
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
VA.
_____________________________
PRODUCT
Platelet, Pheresis, Irradiated (Split unit).
Recall # B-0727-3.
CODE
Unit number 035Z12709.
RECALLING FIRM/MANUFACTURER
American National Red Cross, The Appalachian Region, Roanoke, VA, by telephone on October 24, 2002. Firm initiated recall is complete.
REASON
Blood products, labeled as irradiated but did not meet the requirements for irradiation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
VA.
_____________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0728-3;
b) Platelets, Leukocytes Reduced. Recall # B-0729-3.
CODE
a) and b) Unit number T31342.
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Richmond, VA, by letter on December 5, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from an ineligible donor due to medication with an antibiotic, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
VA.
_____________________________
PRODUCT
Platelets, Irradiated. Recall # B-0730-3.
CODE
Unit number T92324.
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Richmond, VA, by letter on August
19, 2002. Firm initiated recall is complete.
REASON
Blood product, manufactured from a unit of Whole Blood that was underweight, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
VA.
___________________________
PRODUCT
Corneas. Recall # B-0739-3.
CODE
ID number 2002-0681, 2002-0682.
RECALLING FIRM/MANUFACTURER
Transplant Services Center UT, Southwestern Medical Center, Dallas, TX, by letter on December 12, 2002. Firm initiated recall is complete.
REASON
Corneas, collected from a donor who was diagnosed with acute myocarditis, were distributed for transplant.
VOLUME OF PRODUCT IN COMMERCE
2 tissue.
DISTRIBUTION
TX.
PRODUCT
Recovered Plasma. Recall # B-0649-3.
CODE
Units 12C17518, 12H53702, 12P12135, 12Z36587.
RECALLING FIRM/MANUFACTURER
American Red Cross, Carolinas Blood Services Region, Charlotte, NC, by letters dated August 8, 2002, September 6, 2002 and September 9, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was taking the medication Arava, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
TN, GA, NC, CA, NY, and Switzerland.
_____________________________
PRODUCT
Red Blood Cells. Recall # B-0707-3.
CODE
Unit number 71E05847-8.
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Gainesville, FL, by letter on February 6, 2002. Firm initiated recall is complete.
REASON
Blood product, labeled with the incorrect expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
FL.
_____________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0708-3;
Fresh Frozen Plasma. Recall # B-0709-3.
CODE
a) and b) Unit number 084FT25671.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Northern California Region, Oakland, CA, by letter on May 23, 2000. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose arm inspection was not documented, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
CA.
_____________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-0710-3.
CODE
Unit numbers 42KF08475, 42KF08477, and 42KF08478; and the following units were distributed as two split products: unit numbers 42KF08470, 42KF08471, 42KF08472, 42KF08473, and 42KF08474.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Northern Ohio Region, Cleveland, OH, by letter on November 6, 2002. Firm initiated recall is complete.
REASON
Blood products, possibly exposed to unacceptable temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
13 units.
DISTRIBUTION
OH and MI.
_____________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-0711-3.
CODE
Unit numbers 42KF08405, 42KF08407, 42KF08408, 42KF08409, 42KF08411, 42KF08412, 42KF08416; and the following units were distributed as two split products: unit numbers 42KF08406, 42KF08417, 42KF08418, and 42KF08421.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Northern Ohio Region, Cleveland, OH, by letter on November 6, 2002. Firm initiated recall is complete.
REASON
Blood products, possibly exposed to unacceptable temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
15 units.
DISTRIBUTION
OH and MI.
___________________________
PRODUCT
a) Platelets Pheresis, Leukocytes Reduced.
Recall # B-0721-3;
b) Platelets Pheresis, Irradiated. Recall # B-0722-3.
CODE
a) Unit numbers 29FP81221, 29FP81223, 29FP81200, 29FP81209,
29FP81199, 29FP81201, 29FP81213, 29FP81223, 29FP81217,
29FP81218, 29FP81225, 29FP81228, 29FP81214, 29FP81215,
29FP81226, 29FP81227, 29FP81220, 29FP81216, 29FP81205,
29FP81212, 29FP81230; and the following units were
distributed as two split products: units 29FP81211,
29FP81210, 29FP81202, 29FP81219, and 29FP81204;
b) Unit numbers 29FP81225, 29FP81203, 29FP81222, 29FP81201,
29FP81215, 29FP81220, 29FP81222, 29FP81199, 29FP81206,
29FP81208, and 29FP81214
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Mid-Atlantic Region, Norfolk, VA, by letters on August 13, 2002, and September 13, 2002. Firm initiated recall is complete.
REASON
Blood products, exposed to unacceptable temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
a) 31 units;
b) 11 units.
DISTRIBUTION
NC, VA, WV, GA, and CA.
____________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0724-3;
b) Platelets. Recall # B-0725-3;
c) Fresh Frozen Plasma. Recall # B-0726-3.
CODE
a) b) and c) Unit number R74592.
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Richmond, VA, by letter and facsimile on December 4 and 23, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to use of the medication Sulfasalazine, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
VA.
END OF ENFORCEMENT REPORT FOR APRIL 2, 2003
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