August 15, 2001 01-32 RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
_______________________________ RECALL NUMBER, PRODUCT AND CODE: F-478-1, Shirakiku Brand Seasoned Garlic in Liquid (Ninniku Tamari-Zuke), 1 kilo (2.2 pounds) in hermetically sealed plastic bags. Product of Japan. REASON: The product is a low acid food that was manufactured without adherence to federal low acid canned foods regulations. MANUFACTURER/RECALLING FIRM: Shinshin Co., Ltd., Tokyo, Japan. RECALLED BY: Nishimoto Trading Co., Ltd., Carlstadt, NJ, on 8/16/2000, contacted the company sales representatives responsible for the accounts. FIRM INITIATED RECALL: Complete DISTRIBUTION: NJ and NY QUANTITY: 115 cases ______________________________ RECALL NUMBER, PRODUCT AND CODE: F-490-1, E. Wedel Brand Chocolate Covered Gingerbread Cookies with Strawberry Filling CODE: 7.93 oz. (225 gm) and 5.29 oz. (150 gm) Product is in a plastic bag with printed label in various languages reading in part, "E. Wedel Pierniczki ALPEJSKIE NADZIENIE TRUSKAWKOWE***" REASON: The product contains the unapproved color additive Ponceau 4R. MANUFACTURER: Danone Clastka Sp. z o. o., (Polska) Poland RECALLED BY: Cracovia Company LLC, Stamford, CT, NWE-DO visited firm in response to NY sample results revealing the unpermitted color Ponceau 4R. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: 6 New England States, NJ and NY QUANTITY: 310 cases _______________________________ RECALL NUMBER, PRODUCT AND CODE: F-491-1, Sandwich labeled in part "***SoringharT Hazelnut Hummus Pocket** , Produced for East-West Catering at De Casa Fine Foods 1050 Bethel Dr. Eugene, OR 97402 Net Wt. 6 oz." CODE: "03-28" REASON: The product contained undeclared FD&C Yellow No. 5. MANUFACTURER/RECALLING FIRM: Soringhart dba East West Catering, Eugene, OR. RECALLED BY: Upon being advised on 3/27/01 of the labeling error, the firm's owner picked up the remaining 6 sandwiches from the consignees. Product was destroyed by the firm. FIRM INITIATED RECALL: Complete DISTRIBUTION: Eugene, OR QUANTITY: 16 sandwiches _______________________________ RECALL NUMBER, PRODUCT AND CODE: F-495-1, FUN-E-CHIPS, in 10 LB bulk cases. The label states in part. ***DISTRIBUTED BY TARRIER FOODS CORPS, COLUMBUS, OH 43228***COR 167 dairy #0571 PRODUCT OF CANADA CODE:The date code on the case labels is #0571. The Item number is 0669. 'COR 167 DAIRY' is also stamped on the labels. REASON: The product may contain undeclared milk protein. MANUFACTURER/RECALLING FIRM: Neilson International Limited, Toronto, CANADA. RECALLED BY: On 6/12/2001, the firm contacted their sole customer by telephone. FIRM INITIATED RECALL: Complete DISTRIBUTION: MD, IN, MN, PA, OR,MS, AZ,CO, MT, CA, MA and KY QUANTITY: 5,589 cases _______________________________ RECALL NUMBER, PRODUCT AND CODE: Chocolate Lace Brand After Dinner Chocolate products as follows: 1) F-496-1 Original Dark Chocolate in 7 oz. and 14 oz. box and 3.5 oz. pouch. Product in cardboard box with printed label reading in part, "***Chocolate Lace**Original Dark Chocolate**NET WT. 7 OZ.** Ingredients: Chocolate, Sugar, Corn Syrup, Natural Flavors.**Chocolate Lace Bethel, CT 06801***". 2) F-497-1 Toasted Almond Flavor in Milk Chocolate in 7 oz. and 14 oz. box. Product in cardboard box with printed label reading in part, "***Chocolate Lace**Toasted Almond Flavor in Milk Chocolate**NET WT. 7 OZ.** Ingredients: Chocolate, Sugar, Corn Syrup, Natural and Artifical Flavors.**Chocolate Lace Bethel, CT 06801***". 3) F-498-1 Mint Flavor in Dark Chocolate in 7 oz. and 14 oz box. Product in cardboard box with printed label reading in part, "***Chocolate Lace**Mint Flavor in Dark Chocolate**NET WT. 7 OZ.** Ingredients: Chocolate, Sugar, Corn Syrup, Natural Flavors.**Chocolate Lace Bethel, CT 06801***". REASON: The products contain undeclared milk. MANUFACTURER/RECALLING FIRM: Bray Chocolates Inc., dba Chocolate Lace, Bethel, CT RECALLED BY: The firm is conducting a voluntary product field correction by letter to be initiated on 7/7/01. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide QUANTITY: 2000 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: F-499-1, Mills Fleet Farm Butterscotch Bits, Packed for Mills Fleet Farm, Appleton, WI 54911, in two sizes, Net Wt. 1 Lb. 12 Oz. and Net Wt. 12 Oz. F-500-1, Eillien's Butterscotch Chips, in two sizes, net Wt. 12 Oz. and net Wt. 24 Oz. CODE: All lots on the market at the time the recall was initiated. REASON: The product contains undeclared milk ingredients MANUFACTURER/RECALLING FIRM: Clasen Quality Coatings, Inc., Middleton, WI 53562 RECALLED BY: Fleet Farm initiated a stock recovery on 12/26/00 of their brand of the butterscotch chips. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Appleton, WI, and MN, MI, ND and WI QUANTITY: Est.amt.in dist:2855 12 oz. packages and 800 28 oz. packages _______________________________ RECALL NUMBER, PRODUCT AND CODE: F-502-1, Hawaiian Delight Fruit Salad, packed in 4.5 LB and 9 LB plastic tub containers. REASON: The product contains undeclared skim milk and FD&C Red No.40. MANUFACTURER/RECALLING FIRM: Frank L. Harter & Sons, Inc., Cincinnati, OH RECALLED BY: On 7/16,17/2001 the recalling firm contacted each account by telephone. Beginning on 7/18/2001, the recalling firm visited each customer and hand delivered a letter about the nature of the recall. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Cincinnati, OH and Northern KY QUANTITY: 225 LBSRECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
_______________________________ RECALL NUMBER, PRODUCT AND CODE: The following 2 medical food supplemental products are recalled: F-444-1, Re/Neph HP/HC, Vanilla Flavored Renal Supplement F-445-1, Re/Neph FREE, HP/HC, No Sugar Added Lactose Free, Vanilla Flavored Renal Supplement CODE: Batch numbers: a) #692726Lo1, exp.date 9/29/01, Stock Code 60020 b) #7300186L02, exp date 2/1/02, Stock Code 60011 REASON: a) The cartons actually contain Re/Neph Free HP/HC product. B) The cartons actual contain Re/Neph HP/HC product. MANUFACTURER: Prairie Farms Dairy, Inc., Anderson, IN RECALLED BY: Ross Products Division, Abbott Laboratories, Inc. contacted their affected customers by telephone on 3/15/2001. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: PA, TN, MN, KY, MI, TX, NY,OH, FL, NJ, MO, IN AND SC QUANTITY: 939 cases _______________________________ RECALL NUMBER, PRODUCT AND CODE: Taste of the East Rajbhog Sweets brand Indian Sweets: 1) F-479-1: Gajar Halwa Ingredients: Butter, Sugar, Carrots, Nuts, and Food Color Red #3 2) F-480-1: Dudhi Halwa Ingredients: Butter, Sugar, Squash, Nuts, Food Color Yellow 5 and Blue 40 3) F-481-1: Sohan Halwa Ingredients: Flour, Vegetable Oil, Sugar and Nuts 4) F-482-1: Bundi Ladoo Ingredients: Flour, Sugar, Butter, Nuts, Corn Syrup, Food Color Yellow #5/6 5) F-483-1: Bundi Ladoo with Kesar Ingredients: Flour, Sugar, Butter, Nuts, Saffron, Corn Syrup, Food Color Yellow #5/6. 6) F-484-1: Motichar Ladoo Ingredients: Flour, Sugar, Butter, Nuts, Corn Syrup, Food Color Yellow #5/6. 7) F-485-1: Besan Ladoo Ingredients: Flour, Sugar, Butter, and Nuts. 8) F-486-1: Pista Ghari Ingredients: Milk Solid, Sugar, Coloring, Cream of Wheat, Nuts, Food Color Yellow #5 and Blue #40. 9) F-487-1: Halvasan Ingredients: Milk Solid, Flour, Cream of Wheat, Oil, Sugar, and Nuts. 10) F-488-1: Moong Dal Sira Ingredients: Yogurt, Sugar, Saffron, Cardamon, Nutmeg, Nuts, and Food Color Yellow #5/6. The above Indian sweets are sold in clear plastic containers, 1/2 lb. and 1 lb. sizes, and also in 8 lb. aluminum trays. The aluminum trays are sold in bulk without labeling. Firm on Labels - Manufactured by: Rajbhog Foods, Inc., Flushing, NY 11355 CODES: NONE REASON: The labeling of the products failed to identify the specific type of nuts they contain. MANUFACTURER/RECALLING FIRM: Rajbhog Foods, Inc., Flushing, NY RECALLED BY: The firm sent the recall letters on 4/27/01. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: NY, NJ, CT, MA, PA, OH, NC, FL, AL, TN, WI, TX, OK, CO, UT, NV, WA. QUANTITY: Volume per week varies per product. The firm distributes from 50 lbs.(Bundi Ladoo w/Kesar) up to 350 lbs. (Bundi Ladoo) per week. The Moong Dal Sira is only made by special order. _______________________________ RECALL NUMBER, PRODUCT AND CODE: F-489-1, Finest and Finest Natural Walgreens Calcium 500 mg. Elemental Calcium with Vitamin D in 100, 250 and 375 caplet bottles. The product is a dietary supplement. CODE: 1DB0085, 1DB0086, 1DB0087, 1DB1178, 1DB1179, 1EB0546, 1FA0329 REASON: Label states calcium source to be from calcium carbonate instead of oyster shell. MANUFACTURER: Leiner Health Products, Inc., Fort Mill, SC RECALLED BY: Leiner Health Products, Inc., Carson, CA, notified Walgreens of the recall on 7/12/01. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: AZ, CA, FL, IL, PA, TX, WI QUANTITY: 35,070 bottles _______________________________ RECALL NUMBER, PRODUCT AND CODE: F-492-1, Casa Visco brand Jordan Almonds, Net Wt. 9 oz., glass jars Firm on label: Viscusi Wholesale Grocers, Schenectady, NY 12303. REASON: The product contained undeclared FD&C Blue No. 1 and FD&C Red No. 3 MANUFACTURER: Scaccianoce & Co. 1165 Burnett Place Bronx, NY RECALLED BY: Viscusi Wholesale Grocers, Inc., Schenectady, NY FIRM INITIATED RECALL: Complete DISTRIBUTION: A hand written memo dated 10/23/00 issued via fax to one consignee in NYS. Instructions were to stop sale and hold for new labels. New labels were prepared. 22 cases (12 per case) were retrieved from the direct account and relabeled. QUANTITY: Unknown _______________________________ RECALL NUMBER, PRODUCT AND CODE: F-493-1, Caffeine Free Diet Coke in 2 liter bottles F-494-1, Coca-Cola Classic, in 20 oz bottles REASON: The products have an off odor and off flavor MANUFACTURER/RECALLING FIRM: Coca-Cola Enterprises, Inc., Twinsburg, OH RECALLED BY: On 6/6/2001, the recalling firm contacted their sales/distribution centers by email. FIRM INITIATED RECALL: Complete DISTRIBUTION: OH, PA, VA, MD, DE QUANTITY: 20 oz-14,404 cases; 2 liter-5,235 cases _______________________________ RECALL NUMBER, PRODUCT AND CODE: F-501-1 Eillien's Ivory Chips, Net Wt. 12 Oz. REASON: The product does not bear a complete ingredient statement MANUFACTURER/RECALLING FIRM: Clasen Quality Coatings, Middleton, WI RECALLED BY: The stores were notified of the recall by an "Allergy Alert" letters dated February 26, 2001. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: MN, ND, WI, MI QUANTITY: Est.amt. in dist: 2855 12 oz. packages and 800 28 oz. packages.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS I
_______________________________ RECALL NUMBER, PRODUCT AND CODE: D-281-1, Chloroquine Phosphate Bulk Powder, for compounding,in bottles labeled as containing 5, 25, 100, or 500 grams per bottle. The bottles are also labeled as packaged by Universal Chemical, St. Peter, MN Code: Lot UC99020502, Packaged 02/99, CAS 50-63-5 REASON: MIX-UP; BOTTLES LABELED TO CONTAIN CHLOROQUINE PHOSPHATE POWDER WERE FOUND TO CONTAIN CLONIDINE , AN ANTI-HYPERTENSIVE DRUG MANUFACTURER/RECALLING FIRM: China North Industries Nanjing Corporation, Nanjing, China, RECALLED BY: Hawkins Chemical, Inc., Minneapolis, MN, sent Recall letters dated 1/24/01 and 1/25/01 to the direct account and sub-account that received the 5-gram bottles of the drug. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: AZ, CA, FL, LA, MN, OR, SC, TN, UT QUANTITY: The following numbers of bottles of chloroquine phosphate, having lot number UC99020502, were shipped: four 5-gram bottles; twenty 25-gram bottles; twenty 100-gram bottles; and five 500-gram bottlesRECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS I
______________________________ RECALL NUMBER,PRODUCT AND CODE: B-1658-1, Platelets, Pheresis, Leukocytes Reduced, Irradiated, Unit 4250783 REASON: The corresponding split unit of Platelets, Pheresis, was implicated in a transfusion fatality, and was found to be contaminated with Salmonella. The second half of the unit had been distributed MANUFACTURER/RECALLING FIRM: Sylvan N. Goldman Institute, dba Oklahoman Blood Institute, Oklahoma City, OK RECALLED BY: The recalling firm notified Oklahoma consignee by telephone on April 12, 2001, and by facsimile on April 13, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: OK QUANTITY: 1 unitRECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
_______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1315-1, Platelets, unit 53FM43909 REASON: Blood product, corresponding to a unit of Leukoreduced Red Blood Cells, that were implicated in a transfusion reaction, and found to be contaminated with Staphylococcus epidermidis, was distributed. MANUFACTURER/RECALLING FIRM: American Red Cross Blood Services, Greater Chesapeake and Potomac Region, Baltimore, MD RECALLED BY: The recalling firm notified the Maryland consignee by letter dated November 16, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: MD QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1397-1, Urokinase for Catheter Clearance, 9000 IU per 1.8mL vial, units: 00I07017, 00I0401, 00I0101, 00H2101, 00H1401, 00H0701, 00G3101, 00G2401, 00G1701, 00G1001, 00F2901, 00F2601, 00F1901, 00E2401, 00E2201, 00E2001, 00E1001, 00E0801, 00D1701, 00D1501, 00D1301, 00D1101. REASON: Product was not approved, and was manufactured under conditions which were not in compliance with Current Good Manufacturing Practices. MANUFACTURER/RECALLING FIRM: The Medicine Shoppe, Kingsport, TN RECALLED BY: The recalling firm notified nationwide clinics and physicians offices, by telephone on September 28, 2000, and by letters starting September 30, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: Nationwide QUANTITY: 7000 vials _______________________________ RECALL NUMBER, PRODUCT AND CODE: a) B-1551-1, Red Blood Cells, units S01983, S60252; b) B-1552-1, Platelets, unit S60252; c) B-1553-1, Recovered Plasma, units S01983, S60252. REASON: Blood products, collected from a donor who may have been exposed to hepatitis, were distributed. MANUFACTURER/RECALLING FIRM: Michigan Community Blood Center, Saginaw Valley Blood Program, Saginaw, MI RECALLED BY: Michigan Community Blood Center, Grand Valley Blood Program, Grand Rapids, MI., notified the consignees, located in Michigan, New York, and Switzerland, by facsimiles on December 12, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: MI, NY and Switzerland QUANTITY: 5 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1651-1,: Source Plasma, units SA022283, SA761477, SA761447, SA761415, SA761354, SA761253, SA761229, SA761151, SA761114, SA760958, SA760588, SA760567, SA760388, SA760348, SA760287, SA760222, SA760187, SA760147, SA760118, SA760078, SA760042, SA759964, SA759924, SA759733, SA759702, SA759344, SA759319, SA759144, SA758931, SA758895, SA758709, SA758688, SA758630, SA758592, SA758392, SA758152, SA758088, SA758074, SA757885, SA757868, SA757829, SA757684, SA757654, SA757624, SA757519, SA757323, SA757311, SA757282, SA757273, SA757235, SA757197, SA757155, SA757142, SA757093, SA757061, SA757055, 08005090, 07980237, 07978401, 07974007, 07972454 REASON: Blood products, collected from a donor who engaged in high-risk behavior, were distributed. MANUFACTURER/RECALLING FIRM: Sera Tec Biologicals Limited Partnership, Pittsburgh, PA RECALLED BY: Sera Tec Biologicals Limited Partnership, North Brunswick, NJ, by fax dated July 24, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: NC and MD QUANTITY: 61 _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1654-1, Red Blood Cells, unit numbers 20FF10497, 20FF15841, 20FF23097, 20FF28779, 20FF31782, 20FF34935, 20FF43341, 20KM06807, 20LY01273, 20LZ01456, and 20LY03802 B-1655-1, Platelets, unit numbers 20FF10497, 20FF23097, and 20FF31782 B-1656-1, Platelets for Manufacturing Use, unit numbers 20FF15841, 20FF28779, 20FF34935, and 20FF43341 B-1657-1, Recovered Plasma, unit numbers 20FF10497, 20FF15841, 20FF23097, 20FF28779, 20FF31782, 20FF34935, 20FF43341, 20KM06807, 20LY01273, 20LZ01456, and 20LY03802 REASON: Blood products, that tested negative for the antibody to hepatitis C virus (anti-HCV), but were collected from a donor that previously tested reactive to anti-HCV, were distributed. MANUFACTURER/RECALLING FIRM: The American National Red Cross, Lewis and Clark Region, Boise, ID RECALLED BY: The consignees of the transfusable products were notified of the recall by letters dated April 18 and 25, 2000, and non-responding consignees were sent a follow-up letter on May 23, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: ID, Ca, TN and MT QUANTITY: 29 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1659-1: Human tissue for transplantation of the following types: Ilium Bicort Strip 22mm x 6.0cm, serial numbers 034118130028 and 034118130029 Calcaneus cross section 13-15mm, serial numbers 034118130038 and 034118130039 Cancellous Block 3cm x 25mm x 25mm, serial number 034118130007 Iliac Crest Wedge 13-15mm, serial numbers 034118130034 , 034118130035, and 034118130036 Iliac Crest Wedge 24-26mm, serial numbers 034118130030, 034118130031, and 034118130032 Fibula Shaft 4cm, serial numbers 034118130015, 034118130016, and 034118130017 Fibula shaft 8.0cm x 12-13mm, serial number 034118130021 Bone-Tendon-Bone, Whole W/Quadricep, serial numbers 034118130068 and 034118130069 Femur Proximal Right, serial number 034118130006 Cancellous Chips 1.7-10mm, 90cc, serial numbers 034118130011, 034118130012, and 034118130013 REASON: Human tissues for transplantation were distributed and were subsequently reported to have tested repeatedly reactive for hepatitis B surface antigen (HBsAg). MANUFACTURER/RECALLING FIRM: Musculoskeletal Transplant Foundation, Edison, NJ RECALLED BY: The recalling firm notified the consignees of the recall by telephone on May 18, 2001. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: CA, WI, KA, MD, NY, SC, MA, AL, CO, IA, NJ, TX QUANTITY: 46 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1663-1, Red Blood Cells, units 3029608, 6308285 B-1664-1, Platelets, unit 6308285 B-1665-1, Fresh Frozen Plasma, unit 6308285 B-1666-1, Recovered Plasma, unit 3029608 REASON: Blood products, collected from a donor taking the drug Methotrexate, were distributed. MANUFACTURER/RECALLING FIRM: LifeSource, Glenview, IL RECALLED BY: The recalling firm notified Illinois consignees by telephone on November 21 and 22, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: IL QUANTITY: 5 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1667-1, Red Blood Cells, unit 6912790 B-1668-1, Platelets, unit 6912790 B-1669-1, Recovered Plasma, unit 6912790 REASON: Blood products, collected from a donor taking the drug Methotrexate, were distributed. MANUFACTURER/RECALLING FIRM: LifeSource, Glenview, IL RECALLED BY: The recalling firm notified Illinois consignees by telephone on December 26, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: IL QUANTITY: 3 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1670-1, Red Blood Cells, Leukoreduced, unit 12FT89331 B-1671-1, Recovered Plasma, unit 12FT89331 REASON: Blood products, collected from a donor who had been exposed to an individual who is a hepatitis B carrier, were distributed. MANUFACTURER/RECALLING FIRM: American Red Cross Blood Services, Durham, NC RECALLED BY: American Red Cross Blood Services, Carolinas Region, Charlotte, NC, notified the consignee of the red blood cell product, located in North Carolina, by letter dated January 11, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: NC QUANTITY: 2 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1673-1, Red Blood Cells, unit 2208030 B-1674-1, Platelets, unit 2208030 B-1675-1, Fresh Frozen Plasma, unit 2208030 REASON: Blood products, collected from a donor who had a tattoo within twelve months of donation, were distributed. MANUFACTURER/RECALLING FIRM: LifeShare, Inc., Elyria, OH RECALLED BY: The recalling firm notified consignees, located in Ohio, South Carolina, and California, by letters dated April 16, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: OH, SC, CA QUANTITY: 3 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1676-1, Red Blood Cells, Leukoreduced, unit 01Y33686 REASON: Blood product, which was mislabeled as CMV antibody negative, was distributed. MANUFACTURER/RECALLING FIRM: American Red Cross Blood Services, New York-Penn Region, West Henrietta, NY RECALLED BY: The recalling firm notified the New York consignee by telephone on September 14, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: NY QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1678-1, Source Plasma, units G38368-195, G37872-195, G37480-195 REASON: Blood products, collected from a donor who had been incarcerated, were distributed. MANUFACTURER/RECALLING FIRM: Alpha Therapeutic Corporation - SNA, San Antonio, TX RECALLED BY: The recalling firm notified the North Carolina consignee by facsimile dated July 7, 2000 FIRM INITIATED RECALL: Complete DISTRIBUTION: NC QUANTITY: 3 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1679-1, Source Plasma, units 7030120944, 7030120804, 7030120322 REASON: Blood products, collected from a donor who was at increased risk for new variant Creutzfeld Jakob Disease (nvCJD), were distributed. MANUFACTURER/RECALLING FIRM: Nabi BioMedical Center, San Antonio, TX RECALLED BY: The recalling firm notified the United Kingdom consignee by letters on May 11, 2000, and by fax on March 14, 2001 FIRM INITIATED RECALL: Complete DISTRIBUTION: United Kingdom QUANTITY: 3 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1680-1, Source Plasma, unit 28389224 REASON: Blood products, collected from a donor who had not completed the CJD/nvCJD increased risk questions, were distributed. MANUFACTURER/RECALLING FIRM: Nabi BioMedical Center, Dallas, TX RECALLED BY: The recalling firm notified the California consignee by facsimile on June 19, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: CA QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1681-1, Red Blood Cells, Leukocytes Reduced, unit 04LE21445 B-1682-1, Platelets, unit 04LE21445 REASON: Blood products, collected from a donor who reported having lived in an area designated as endemic for malaria, were distributed. MANUFACTURER/RECALLING FIRM: American Red Cross, New England Region, Dedham, MA RECALLED BY: The recalling firm notified Massachusetts consignees by letters on March 2, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: MA QUANTITY: 2 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1684-1, Red Blood Cells, Leukoreduced, unit number FJ60026 REASON: Blood product, collected from a donor whose hemaglobin/hematocrit had not been documented, was distributed. MANUFACTURER/RECALLING FIRM: Healthcare Provider Services Inc., dba Rhode Island Blood Center, Providence, RI. RECALLED BY: The recalling firm notified the Rhode Island consignee, on January 5, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: R.I. QUANTITY 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1693-1, Red Blood Cells, Leukocytes Reduced, unit numbers 5091112 REASON: Blood product, that tested negative for the antibody to hepatitis B core antigen (anti-HBc), but was collected from a donor that previously tested repeatedly reactive for anti-HBc on more than one occasion, was distribution. MANUFACTURER/RECALLING FIRM: Coffee Memorial Blood Center, Amarillo, TX RECALLED BY: The recalling firm notified the consignee, located in TX, of the recall by letter dated June 22, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: TX QUANTITY 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1753-1, Red Blood Cells, Leukoreduced, unit FM28100 REASON: Blood product, collected from a donor who reported travel to an area designated as endemic for malaria, was distributed MANUFACTURER/RECALLING FIRM: Healthcare Provider Services Inc., Providence, RI RECALLED BY: The recalling firm notified the Rhode Island consignee by telephone on March 30, 2001, and was informed that the unit had been transfused. FIRM INITIATED RECALL: Complete DISTRIBUTION: R.I. QUANTITY 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1771, Red Blood Cells, Leukoreduced, unit 13FY60963 REASON: Blood product, collected from a donor taking the drug Mercaptopurine, was distributed. MANUFACTURER/RECALLING FIRM: American Red Cross Blood Services, Detroit, MI RECALLED BY: The recalling firm notified a Michigan consignee by letter on April 12, 2001, and was informed that the unit had been transfused. FIRM INITIATED RECALL: Complete DISTRIBUTION: MI QUANTITY 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1694-1, Red Blood Cells, unit numbers 4318293 and 4304784 B-1695-1, Platelets, unit numbers 4318293 and 4304784 B-1696-1, Recovered Plasma, unit numbers 4318293 and 4304784 REASON: Blood products, that tested negative for hepatitis, but were collected from an unsuitable donor based on previous reactive hepatitis testing, were distributed. MANUFACTURER/RECALLING FIRM: LifeSource, Glenview, IL RECALLED BY: The recalling firm notified the consignees of the transfusable products by telephone on March 19 and 20, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: IL and Scotland QUANTITY: 6 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1697-1, Red Blood Cells, unit number 3809592 B-1698-1, Cryoprecipitated AHF, unit number 3809592 B-1699-1, Recovered Plasma, unit number 3809592 REASON: Blood products, that tested negative for hepatitis, but were collected from an unsuitable donor based on previous reactive hepatitis testing, were distributed. MANUFACTURER/RECALLING FIRM: Blood Systems, Inc., Permian Basin Blood Institute, Midland, TX RECALLED BY: The recalling firm notified consignees, located in Texas and California, of the recall by telephone and letter on October 14, 1999. FIRM INITIATED RECALL: Complete DISTRIBUTION: TX and CA QUANTITY: 3 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1700-1, Red Blood Cells, unit numbers 5133770, 3770099 (2 spilt units distributed), and 3749496 B-1701-1, Red Blood Cells, Leukocytes Reduced, unit number 3710443 B-1702-1, Cryoprecipitated AHF, unit number 5133770 B-1703-1, Fresh Frozen Plasma, unit number 3749496 B-1704-1, Recovered Plasma, unit number 3710443 REASON: Blood products, that tested negative for antibodies to human immunodeficiency virus, types 1 and 2 (anti-HIV-1/2), and antibody to hepatitis C virus (anti- HCV), but were collected from donors that previously tested repeatedly reactive to anti-HIV or anti-HCV, were distributed. MANUFACTURER/RECALLING FIRM: Sylvan N. Goldman Center, Oklahoma Blood Institute, Oklahoma City, OK RECALLED BY: The recalling firm notified the consignees of the recall by letters on or about June 10, 2000, and January 11, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: TX and Switzerland QUANTITY: 8 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1711-1, Red Blood Cells, unit number 24KM58751 B-1712-1, Platelets, unit number 24KM58751 B-1713-1, Fresh Frozen Plasma, unit number 24KM58751 REASON: Blood products, that tested negative for hepatitis, but were collected from an unsuitable donor based on previous reactive hepatitis testing, were distributed. MANUFACTURER/RECALLING FIRM: The American National Red Cross, River Valley Region, Louisville, KY RECALLED BY: The recalling firm notified consignees, located in Kentucky, of the recall by letter dated April 10, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: KY QUANTITY: 3 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1714-1, Red Blood Cells, unit number 24GV11630 B-1715-1, Recovered Plasma, unit number 24GV11630 REASON: Blood products, that tested negative for hepatitis, but were collected from an unsuitable donor based on previous reactive hepatitis testing, were distributed. MANUFACTURER/RECALLING FIRM: The American National Red Cross, River Valley Region, Louisville, KY RECALLED BY: The recalling firm notified consignees, located in Indiana and California, of the recall by letters on January 30, 2001 and February 2, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: IN and CA QUANTITY: 2 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1716-1, Red Blood Cells, Leukocytes Reduced, unit number 50C04091 REASON: Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed. MANUFACTURER/RECALLING FIRM: The American National Red Cross, Western Lake Erie Region, Toledo, OH RECALLED BY: The recalling firm notified the consignee, located in Michigan, of the recall by letter dated February 7, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: MI QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1717-1, Red Blood Cells, unit number 50LH14269 REASON: Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed. MANUFACTURER/RECALLING FIRM: The American National Red Cross, Western Lake Erie Region, Toledo, OH RECALLED BY: The recalling firm notified the consignee, located in Ohio, of the recall by letter dated February 7, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: OH QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1718-1, Red Blood Cells, unit number 50X14779 REASON: Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed. MANUFACTURER/RECALLING FIRM: The American National Red Cross, Western Lake Erie Region, Toledo, Ohio RECALLED BY: The recalling firm notified the consignee, located in Ohio, of the recall by letter dated December 27, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: OH QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1719-1, Red Blood Cells, unit number 16LY92081 REASON: Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed. MANUFACTURER/RECALLING FIRM: The American National Red Cross, Central Ohio Region, Columbus, OH RECALLED BY: The recalling firm notified the consignee, located in Ohio, of the recall by letter dated January 29, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: OH QUANTITY 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1720-1, Platelets Pheresis (7 units), unit numbers 7574655, 7574489, 7575312, 7575177, 7574876, 7574698, and 7574218 REASON: Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed. MANUFACTURER/RECALLING FIRM: Carter BloodCare, Bedford, TX RECALLED BY: The recalling firm notified consignees, located in Texas, of the recall by letters on July 27, 2000, and August 11, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: TX QUANTITY 7 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1721-1, Red Blood Cells, unit numbers 2131157 and 2132484 B-1722-1, Platelets, unit numbers 2131157 and 2132484 REASON: Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed. MANUFACTURER/RECALLING FIRM: LifeShare, Inc., Elyria, OH RECALLED BY: The recalling firm notified consignees, located in Ohio and California, of the recall by letter dated April 18, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: OH and CA QUANTITY: 4 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1742-1, Platelets Pheresis, Leukocytes Reduced, unit numbers C14075C and C14075D REASON: Blood products, collected from an ineligible donor due to medication with Furosemide (Lasix), were distributed. MANUFACTURER/RECALLING FIRM: Tacoma-Pierce County Blood Bank, Cascade Regional Blood Services, Tacoma, WA RECALLED BY: The recalling firm notified consignees, located in Arizona and New York, of the recall by telephone and letter on January 30, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: AZ and NY QUANTITY: 2 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1743-1, Red Blood Cells, Leukoreduced, unit 7558728 REASON: Blood product, collected from a donor who had traveled to an area designated as endemic for malaria, was distributed. MANUFACTURER/RECALLING FIRM: Carter BloodCare, Bedford, TX RECALLED BY: The recalling firm notified the Texas consignee by telephone on November 16, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: TX QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1744-1, Red Blood Cells, unit 5084104 REASON: Blood product, collected from a donor whose hemaglobin had not been documented, was distributed. MANUFACTURER/RECALLING FIRM: Carter BloodCare, Bedford, TX RECALLED BY: The recalling firm notified the Texas consignee by letter dated February 26, 1999, and was informed that the unit had been transfused. FIRM INITIATED RECALL: Complete DISTRIBUTION: TX QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1747-1, Red Blood Cells, unit 24KC22025 B-1748-1, Platelets, unit 24KC22025 B-B-1749-1, Fresh Frozen Plasma, unit 24KC22025 REASON: Blood products, collected from a donor who was taking an experimental drug, were distributed. MANUFACTURER/RECALLING FIRM: American National Red Cross Blood Services, River Valley Region, Louisville, KY RECALLED BY: The recalling firm notified consignees, located in Indiana and Kentucky, by telephone on April 25, 2001, and by letters dated April 30, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: IN and KY QUANTITY: 3 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1750-1, Fresh Frozen Plasma, unit 24FH25076 REASON: Unit of Platelets, implicated in a transfusion reaction, were found to be contaminated with coagulase-negative staphylococcus. A corresponding blood product was distributed. MANUFACTURER/RECALLING FIRM: American National Red Cross Blood Services, Louisville, KY RECALLED BY: The recalling firm notified the Kentucky consignee by telephone on March 29, 2001, and by letter dated April 3, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: KY QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1752-1, Source Plasma, units 0024113, 0024467, 0024885 REASON: Blood products, collected from a donor who was at increased risk for new variant Creutzfeld Jakob Disease (nvCJD), were distributed MANUFACTURER/RECALLING FIRM: DCI Biologicals Bryan, Inc., Bryan, TX RECALLED BY: The recalling firm notified the Austrian consignee, through a New York broker, by facsimile on July 26, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: Austria QUANTITY: 3 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1751-1, Red Blood Cells, unit C17422 REASON: Blood product, collected from a donor who reported travel to an area designated as endemic for malaria, was distributed. MANUFACTURER/RECALLING FIRM: Aurora Area Blood Bank, Heartland Blood Centers, Aurora, IL RECALLED BY: The recalling firm notified the Illinois consignee by letter dated May 15, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: IL QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1760-1, Source Plasma, units 0015571, 0017611, 0017991, 0018359, 0018769, 0019891, 0020385, 0021749, 0022197, 0022305, 0022765, 0023327, 0023437, 0024685, 0024784, 0025062, 025200, 0026567,0026949, 0027592, 0027852, 0028217, 0028485 REASON: Blood products, collected from an unsuitable donor, were distributed MANUFACTURER/RECALLING FIRM: DCI Biologicals Bryan, Inc., Bryan, TX RECALLED BY: The recalling firm notified the New York broker by letter dated August 8, 2000 who in turn notified the Austrian consignee of the recalled units by fax on August 9, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: Austria QUANTITY: 23 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1754-1, Red Blood Cells, Leukoreduced, unit FG37427 B-1755-1, Platelets, unit FG37427 B-1756-1, Fresh Frozen Plasma, unit FG37427 REASON: Blood products, collected from a donor whose body temperature had not been documented, were distributed. MANUFACTURER/RECALLING FIRM: Healthcare Provider Services Inc., Providence, RI RECALLED BY: The recalling firm notified three Rhode Island consignees by telephone on December 11, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: R.I. QUANTITY: 3 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1763-1, Platelet Pheresis, Leukoreduced, unit 04GH05165 REASON: Blood product, inappropriately prepared by recording the incorrect volume on the label, which resulted in the product being distributed in one platelet bag instead of two. MANUFACTURER/RECALLING FIRM: American Red Cross, Dedham, MA RECALLED BY: The recalling firm notified the consignee located in Massachusetts by telephone on March 19, 2001 and by letter dated April 9, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: MA QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1764-1, Red Blood Cells, unit 2209341 B-1765-1, Platelets, unit 2209341 REASON: Blood Products, collected from a donor whose suitability was not adequately determined, were distributed. MANUFACTURER/RECALLING FIRM: LifeShare, Inc., Elyria, Ohio RECALLED BY: The recalling firm notified the consignee located in Ohio by letter dated May 10, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: OH QUANTITY: 2 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1768-1, Red Blood Cells, unit 0333642 B-1769-1, Red Blood Cells Leukoreduced, unit 0323125 B-1770-1, Platelets, unit 0323125 REASON: Blood products, collected from a donor who reported travel to an area designated as endemic for malaria, were distributed. MANUFACTURER/RECALLING FIRM: Community Blood Center of Greater Kansas, Kansas City, MO RECALLED BY: The recalling firm notified Missouri consignees by letters dated July 14, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: MO QUANTITY: 3 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1773-1, Source Plasma, units 01GMIA7860, 01GMIA8157, 01GMIA8936, 01GMIA9230, 01GMIA9961, 01GMIB0273, 01GMIB1037, 01GMIB1354, 01GMIB2108, 01GMIB2425 REASON: Blood products, collected from a donor who had been incarcerated, were distributed. MANUFACTURER: Community Bio-Resources, Inc., Grand Rapids, MI RECALLED BY: Community Bio-Resources, Inc., Hoover, Alabama, notified the consignee, located in Austria, by facsimile on April 30, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: Austria QUANTITY: 10 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1774-1, Red Blood Cells, unit 21KK18590 REASON: Blood product that was not quarantined after receiving information concerning a post donation illness, was distributed. MANUFACTURER/RECALLING FIRM: American Red Cross Blood Services, Southern Region, Atlanta, GA RECALLED BY: The recalling firm notified the South Carolina consignee by telephone on November 26, 1999. FIRM INITIATED RECALL: Complete DISTRIBUTION: SC QUANTITY: 1 unitRECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
_______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1316-1, Collagenase, Santyl Ointment, Lots 0000067143, 0000067144 REASON: Subsequent to release, the product was found to exceed the potency specification. MANUFACTURER/RECALLING FIRM: Advance Biofactures Corporation, a subsidiary of Biospecifics Technologies Corporation, Lynbrook, NY RECALLED BY: The recalling firm, by certified letters on March 12, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: Nationwide QUANTITY: 19,548 tubes were distributed _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1604-1, Roferon-A Injection, Interferon alfa-2a, recombinant, Prefilled Syringes, 9 Million IU/0.5 mL per syringe, Lots 2003, 2003-02 - Expiration dates 10/2000 REASON: During the 12 month stability testing of the product, an interferon degradant was found. MANUFACTURER: F. Hoffmann La Roche Ltd., Basel, Switzerland RECALLED BY: Hoffmann La Roche, Inc., Nutley, NJ, notified consignees, located throughout the United States, by letters dated June 14, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: Nationwide QUANTITY: 8,011 vials distributed _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1652-1 Reagent Red Blood Cells, Coombs Control Cells (Strong), Lot 0508299, expired June 13, 2001 Reagent Red Blood Cells, Screening Duet, Lot 0502304, expired June 13, 2001 Reagent Red Blood Cells, Complement Coombs Control (EC3b), Lot 0529344, expires July 4, 2001 REASON: Reagent Red Blood Cells, which may hemolyze prematurely due to microbial contamination, were distributed. MANUFACTURER/RECALLING FIRM: Gamma Biologicals, Inc., Houston, TX RECALLED BY: The recalling firm notified nationwide consignees by two letters mailed or faxed on May 24, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: Nationwide QUANTITY: 3 lots _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1660-1, Fresh Frozen Plasma, unit 91-90588 REASON: Blood product, prepared from a unit of Whole Blood with a documented extended collection time, was distributed. MANUFACTURER/RECALLING FIRM: Medic Regional Blood Center, Knoxville, TN RECALLED BY: The recalling firm notified the Tennessee consignee by telephone on October 17, 2000, and by letter dated October 20, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: TN QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1662-1, Red Blood Cells, Leukoreduced, unit 95-35180 REASON: Red Blood Cells, leukoreduced by filtration greater than five days past the time of collection, was distributed. MANUFACTURER/RECALLING FIRM: Medic Regional Blood Center, Knoxville, TN RECALLED BY: The recalling firm notified the Tennessee consignee by letter dated October 11, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: TN QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1672-1, Red Blood Cells, units 12Q80995, 12M69417 REASON: Blood products, collected from a donor with a history of Idiopathic Thrombocytopenic Purpura, were distributed MANUFACTURER/RECALLING FIRM: American Red Cross Blood Services, Charlotte, NC RECALLED BY: The recalling firm notified North Carolina consignees by letters dated August 11, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: NC QUANTITY: 2 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1677-1, Red Blood Cells, unit C29094 REASON: Blood product, collected from a donor whose arm inspection had not been documented, was distributed. MANUFACTURER/RECALLING FIRM: Aurora Area Blood Bank, Heartland Blood Centers, Aurora, IL RECALLED BY: The recalling firm notified the Illinois consignee by telephone on April 23, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: IL QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1683-1, Red Blood Cells, unit FJ49829 REASON: Blood product, labeled with an extended expiration date, was distributed. MANUFACTURER/RECALLING FIRM: Healthcare Provider Services Inc., Providence, RI 02908 RECALLED BY: The recalling firm notified the Rhode Island consignee by telephone on August 30, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: R.I. QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1705-1 Red Blood Cells, unit numbers 3730382, 3770991, 5140574, and 5140864 (2 spilt units distributed) B-1706-1 Red Blood Cells, Leukocytes Reduced, unit number 3770770 B-1707-1 Cryoprecipitated AHF, unit number 5140574 B-1708-1 Fresh Frozen Plasma, unit number 5136402 B-1709-1 Recovered Plasma, unit number 3730382 REASON: Blood products, that tested negative for antibodies to human immunodeficiency virus, types 1 and 2 (anti-HIV-1/2), and antibody to hepatitis C virus (anti- HCV), but were collected from donors that previously tested repeatedly reactive to anti-HIV or anti-HCV, were distributed. MANUFACTURER/RECALLING FIRM: Sylvan N. Goldman Center, Oklahoma City, OK RECALLED BY: The recalled products were distributed to seven consignees in Texas and Switzerland. The recalling firm notified the consignees of the recall by letters on or about June 10, 2000, and January 11, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: TX and Switzerland QUANTITY: 9 units ______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1741-1, Fresh Frozen Plasma (23 units), unit numbers 50C06082, 50C06085, 50C06086, 50C06088, 50C06089, 50C06090, 50C06092, 50C06093, 50C06095, 50C06096, 50C06097, 50C06099, 50C06100, 50C06103, 50C06104, 50C06105, 50C06106, 50C06107, 50C06109, 50LH18742, 50LH18745, 50LH18746, and 50LH18748 REASON: Blood products, manufactured using a centrifuge that was found to be at an incorrect temperature, were distributed. MANUFACTURER/RECALLING FIRM: The American National Red Cross, Toledo, OH RECALLED BY: The recalling firm notified the consignees, located in Ohio, of the recall by telephone on January 5, 2001 and by letter dated January 17, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: OH QUANTITY: 23 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1746-1, Recovered Plasma, unit LL62466 REASON: Blood product, that was not quarantined after receiving information concerning a post donation illness, was distributed. MANUFACTURER/RECALLING FIRM: Mid-South Regional Blood Center, Memphis, TN RECALLED BY: The recalling firm notified the Florida consignee by letter dated August 2, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: FL QUANTITY: 1 unitRECALLS AND FIELD CORRECTIONS: VETMED -- CLASS III
_______________________________ RECALL NUMBER, PRODUCT AND CODE: V-396-1, Pro-Gen 20% Arsanilic Acid (90 Grams per Pound) Type A Medicated Article packaged in 50 pound bags. This product is used in manufacturing medicated feeds for swine to increase the rate of weight gain and improved feed efficiency, and for chickens and turkeys to promote growth, feed efficiency, and to improve pigmentation. Codes: Lots 0100238E, 0100239E, 0100240E, 0100241E, 0100242E, 010096E, 010097E, 010098E, 010099E, 0100100E REASON: The product was mislabeled under the Active Drug Ingredient statement as Arsanilic Acid 20% (90 grams per kilo) instead of Arsanilic Acid 20% (90 grams per pound). MANUFACTURER/RECALLING FIRM: ADM Animal Health and Nutrition Division, Effingham, Illinois RECALLED BY: ADM telephoned the three feed mills in Illinois on March 9, 2001, informing them of the labeling error, and asked them to place the remainder of the affected lots on hold for pick-up by ADM for replacement. FIRM INITIATED RECALL: Complete DISTRIBUTION: IA and IL QUANTITY: 30,400 poundsEND OF ENFORCEMENT REPORT FOR August 15, 2001. ####
Office of Public Affairs
Hypertext uploaded by clb
2001-AUG-16.