November 14, 2001 01-45
RECALLS AND FIELD CORRECTIONS: FOODS CLASS II
_______________________ PRODUCT Alaska Supreme brand ice cream in 1/2 gallon cardboard containers. Flavors include: a) China Green Tea, Recall #F-031-2; b) Mint Chip, Recall #F-032-2; c) Cappuccino, Recall #F-033-2. CODE Pull dates up through June 19, 2002. RECALLING FIRM/MANUFACTURER Alaska Supreme Ice Cream, Inc. Anchorage, AK, by on site visit on 9/20/01. Firm initiated recall is complete. REASON The products contained undeclared FD&C Yellow No. 5. VOLUME OF PRODUCT IN COMMERCE Unknown. DISTRIBUTION Anchorage, AK.RECALLS AND FIELD CORRECTIONS: FOODS CLASS III
_______________________ PRODUCT a) Health from the Sun Liquid Gold Flax Oil, 16 fl.oz., bottles HEALTH FROM THE SUN FLAX LIQUID GOLD OCIA CERTIFIED ORGANIC COLD-PRESSED FLAX OIL Vegetable Source of Omega-3 Fatty Acids 16.0 FL. OZ. 472ML****Marketed by: Health from the Sun ***A Division of Arkopharma***Newport,NH 03773*** product of Canada***", Recall #F-034-2. b) Health from the Sun Total EFA Liquid, 16 fl. oz. bottles. Lableled in part:"HEALTH FROM THE SUN The Total EFA MEETS YOUR DAILY ESSENTIAL FATTY ACID NEEDS Vegetarian EFA Oil Blend with Lignans 16.0 Fl OZ 472 ML ****Marketed by: Health from the Sun ***A Division of Arkopharma***Newport,NH 03773*** product of Canada***", Recall #F-035-2. CODE a) Health from the Sun Liquid Gold Flax Oil, 16 fl. oz., Lot number: 101284, Exp. Date: June, 2002. b) Health from the Sun Total EFA Liquid, 16 fl. oz., Lot Number: 101205, Exp. Date: April, 2002. RECALLING FIRM/MANUFACTURER Recalling Firm: Health from the Sun, A Division of Arkopharma, Inc., Newport, NH, initiated the recall by fax on 8/27/01 to the direct accounts-distributors. Manufacturer: Bioriginal Food Service and Science Corp., Saskatoon, Saskatchen. Firm initiated recall ongoing. REASON Some of the product may contain water instead of the labeled oil. VOLUME OF PRODUCT IN COMMERCE a) 3,256 bottles; b) 1,472 bottles. DISTRIBUTION Nationwide and Canada.RECALLS AND FIELD CORRECTIONS: DRUGS CLASS II
_______________________ PRODUCT Lantus Insulin Glargine (rDNA origin) Injection; 100 units/mL (U-100)in 10 mL vials, 10 vials per pack; NDC #0088-2220-33, Recall # D-029-2. CODE All lots of Lantus U-100 Insulin distributed to Walgreens pharmacies between 5/2/01 and 9/7/01. RECALLING FIRM/MANUFACTURER Recalling Firm: Walgreen Co., Deerfield, IL, by e-mail on 9/7/01. Manufacturer: Aventis Pharma AG Frankfurt am Main, Germany. Firm initiated recall is complete. REASON Temperature Abuse-product shipped unrefrigerated by recalling firm. VOLUME OF PRODUCT IN COMMERCE 38,000 vials. DISTRIBUTION Nationwide. _______________________ PRODUCT Oxygen, USP, compressed, packaged in #2 high pressure Cylinders, Recall #D-030-2. CODE 12892001/11, 12892001/12, 12892001/13, 12892001/18, 12892001/20, 12902001/8, 12902001/12. RECALLING FIRM/MANUFACTURER Nexair, LLC Memphis, TN, telephoned its branch stores and customers on 10/18/01. Firm initiated recall is ongoing. REASON Cylinders were contaminated with oil in and around the valve threads. VOLUME OF PRODUCT IN COMMERCE 22 cylinders. DISTRIBUTION TN and AR. _______________________ PRODUCT Timoptic-XE (Timolol Maleate Ophthalmic Gel Forming Solution) 0.5% Timolol Equivalent (Timolol Maleate 6.8 mg/mL), Rx only, 5 ml Ophthalmic Dispenser, NDC number 03558-03-00, Recall #D-033-2. CODE Lot # 0304L exp. 12/02. RECALLING FIRM/MANUFACTURER Merck & Co., Inc., West Point, PA, on 9/26/01, sent recall letters. Firm initiated recall is ongoing. REASON Lack of assurance of sterility. VOLUME OF PRODUCT IN COMMERCE 74,671 units. DISTRIBUTION Nationwide.RECALLS AND FIELD CORRECTIONS: DRUGS CLASS III
_______________________ PRODUCT Fluocinolone Acetonide Topical Solution, USP, 0.01%, For External Use Only, Not for Ophthalmic Use, Rx only,20 mL and 60 mL plastic bottles. The Thames brand 20 mL bottle has a white and blue colored label, and is labeled in part, "xxx NDC 49158-209-40 xxx FLUOCINOLONE ACETONIDE xxx SOLUTION xxx USP, 0.01% xxx Rx only xxx 20 mL xxx Thames PHARMACAL CO., INC. xxx Ronkonkoma, N.Y. 11779 USA xxx". The Thames brand 60 mL bottle is white and blue colored label, and is labeled in part, "xxx NDC 49158-209-32 xxx FLUOCINOLONE ACETONIDE xxx SOLUTION USP, 0.01% xxx Rx only xxx 60 mL xxx Thames PHARMACAL CO., INC. xxx Ronkonkoma, N.Y. 11779 USA xxx". The Qualitest brand 20 mL bottle has a brown and beige colored label, and is labeled in part, "xxx NDC 0603-1231-43 xxx FLUOCINOLONE ACETONIDE xxx TOPICAL SOLUTION USP, 0.01% xxx Mfg. for: QUALITEST PHARMACEUTICALS, INC., xxx HUNTSVILLE, AL 35811 xxx Rx only xxx NET CONTENTS 20 mL xxx Qualitest(R) xxx". The Qualitest brand 60 mL bottle has a brown and beige colored label, and is labeled in part, "xxx NDC 0603-1231-49 xxx FLUOCINOLONE ACETONIDE xxx SOLUTION USP, 0.01% xxx Mfg. for: QUALITEST PHARMACEUTICALS, INC., xxx HUNTSVILLE, AL 35811 xxx NET CONTENTS 60 mL xxx Qualitest(R) xxx". The Schein Pharmaceutical brand 60-mL bottle has blue and white colored label, and is labeled in part, ìxxx SCHEIN PHARMACEUTICAL xxx NDC 0364-7343-58 xxx FLUOCINOLONE ACETONIDE xxx Topical Solution, USP, xxx 0.01% xxx Mfd. for: Schein Pharmaceutical, Inc. xxx Florham Park, NJ 07932 USA xxx 60 mL xxxî. The Major Pharmaceuticals brand 60-mL bottle has a blue, red and green colored label, and is labeled in part, ìxxx NDC 0904-2661- 03 xxx Fluocinolone Acetonide xxx Topical Solution USP, xxx 0.01% xxx Rx only xxx 60 mL xxx MAJOR(R) PHARMACEUTICALS xxx Distributed by Major Pharmaceuticals xxx Livonia, MI 48150 USA xxxî. Recall #D-024-2 CODE Lots: N304 (exp. 7/2002), N409 (exp. 7/2002), N588 (exp. 12/2002), N660 (exp. 2/2003) Thames NDC: 49158-209-40 (20 mL), 49158-209-32 (60 mL)Qualitest NDC: 0603-1231-43 (20 mL), 0603- 1231-49 (60 mL) Schein NDC: 0364-7343-58 (60 mL). Major NDC: 0904-2661-03 (60 mL). PLEASE NOTE: Schein Pharmaceutical labeled product in 20 mL bottles with NDC 0364-7343-55 listed in the 24 Hour Alert was not included in the RR as it was discovered that it had not been distributed. RECALLING FIRM/MANUFACTURER Thames Pharmacal Co., Inc. Ronkonkoma, NY, by letter, dated 10/3/01. Firm initiated recall is ongoing. REASON Subpotency (12 month stability). VOLUME OF PRODUCT IN COMMERCE A total of 73,612 bottles: 37,696 - 20 mL bottles and 35,916 - 60 mL bottles. DISTRIBUTION Nationwide and Puerto Rico. _______________________ PRODUCT Chlor-Trimeton Allergy 8 hour tablets, Chlorphenirmaine maleate, 8 mg per tablet, 15 tablets, blister packaged. The product is labeled in part: Chlor-Trimeton Antihistamine Allergy 8 Hour 15 tablets Schering- Plough HealthCare Products, Inc. Memphis, TN. Inside each carton is a foil blister of fifteen (15) tablets labeled in part: Chlor-Trimeton 8 Hour Allergy Tablets 7-CC-2 EXP 1/02 Schering- Plough HealthCare Products, Inc. Memphis, TN Recall #D-025-2 CODE Lot No. 7-CC-2, Expiration January 2002. RECALLING FIRM/MANUFACTURER Recalling Firm: Schering Plough Healthcare Products, Cleveland, TN, by letter dated October 5, 2001. Manufacturer: Schering Laboratories Kenilworth, NJ. Firm initiated recall is ongoing. REASON Dissolution Failure at 2 hour test time (Stability 50th month). VOLUME OF PRODUCT IN COMMERCE 154,404. DISTRIBUTION Nationwide and Puerto Rico. _______________________ PRODUCT Atarax tablets (hydroxyzine HCl), 10 mg, 100 Tablet bottles, Rx only, NDC 0049-5600-66, Pfizer Roerig, Division of Pfizer, Inc., NY, NY, Recall #D-026-2. CODE Lot # 0105K00A, expiration date 7/2002, NDC 0049-5600-66, Item #4341. RECALLING FIRM/MANUFACTURER Recalling Firm: Pfizer, Inc. New York, NY, by letter dated 10/9/01. Manufacturer: Pfizer, Inc. Brooklyn, NY. Firm initiated recall is ongoing. REASON Dissolution failure (12th month stability). VOLUME OF PRODUCT IN COMMERCE 24,140 bottles were distributed. DISTRIBUTION Nationwide and Puerto Rico, Trinidad, Bahamas and St. Marten. _______________________ PRODUCT a) BETCO brand Premium Antibacterial Hand Cleaner with Aloe (catalog #73644) - Active Ingredient - Chloroxylenol 0.5%, Recall # D-027-2. The recalled products are packed and distributed in the following size/type containers: Premium Antibacterial Hand Cleaner (#73644): 55-gallon drums; sold individually - NDC #65601-736-55; 5-gallon pails; sold individually - NDC #65601-736-05; 1-gallon containers; 4 per case - NDC #65601-736-04; 16 oz bottles; 12 per case - NDC #65601-736-36; 8 oz bottles; 12 per case - NDC #65601-736-68; 4 oz bottles; 24 per case - NDC #65601-736-24; 1100 ml Bag-In-Box; 10 per case - NDC #65601-736-10; 900 ml Bag-In-Box; 12 per case - NDC #65601-736-19; 500 ml Bag-In-Box; 18 per case - NDC #65601-736-88; b) BETCO brand Winning Hands Pearlized Antiseptic Lotion Hand Cleaner (catalog #14104) - Active Ingredient - Chloroxylenol 0.375%, Recall # D-028-2. Winning Hands Pearlized Antiseptic Lotion Hand Cleaner (#14104): 55-gallon drums; sold individually - NDC #65601-141-55; 5-gallon pails; sold individually - NDC #65601-141-05; 1-gallon containers; 4 per case - NDC #65601-141-04; 4 oz bottles; 24 per case - NDC #65601-141-24; 1100 ml Bag-In-Box; 10 per case - NDC #65601-141-10; 900 ml Bag-In-Box; 12 per case - NDC #65601-141-19; 500 ml Bag-In-Box; 18 per case - NDC #65601-141-88; CODE a) Premium Antibacterial Hand Cleaner with Aloe (#73644): Lot Numbers: 2690, 2770, 2850, 2980, 3010, 3080, 3210, 3320, 3410, 3460, 3540, 0041, 0521, 0651, 0781, 0871, 0941, 1011, 1161, 1211, 1281, 1371, 1431, 1571, 1601, 1691, 1761, 1901, 1931, 1971, 2061, 2071, 2131, 2201, 2291, 2351, 2491, 2531, 2571, 2611. Expiration Dates: 9/25/2001, 10/3/2001, 10/11/2001, 10/24/2001, 10/27/2001, 11/3/2001, 11/16/2001, 11/27/2001, 12/6/2001, 12/11/2001, 12/19/2001, 1/4/2002, 1/9/2002, 1/16/2002, 1/25/2002, 1/31/2002, 2/10/2002, 2/21/2002, 3/6/2002, 3/19/2002, 3/28/2002, 4/4/2002, 4/11/2002, 4/26/2002, 5/1/2002, 5/8/2002, 5/17/2002, 5/23/2002, 6/6/2002, 6/9/2002, 6/18/2002, 6/25/2002, 7/9/2002, 7/12/2002, 7/16/2002, 7/25/2002, 7/26/2002, 8/1/2002, 8/8/2002, 8/17/2002, 8/23/2002, 9/6/2002, 9/10/2002, 9/14/2002, 9/18/2002. b) Winning Hands Pearlized Antiseptic Lotion Hand Cleaner (#14104): Lot Numbers: 2710, 2770, 2920, 2990, 3040, 3140, 3220, 3340, 3400, 3490, 3560, 0041, 0111, 0221, 0241, 0321, 0441, 0471, 0591, 0671, 0791, 0861, 0931, 0991, 1131, 1231, 1291, 1421, 1561, 1591, 1691, 1721, 1801, 1871, 1941, 2041, 2081, 2191, 2251, 2281, 2331, 2411, 2491, 2571, 2641. Expiration dates: 9/28/2001, 10/3/2001, 10/18/2001, 10/25/2001, 10/30/2001,11/9/2001, 11/17/2001, 11/29/2001, 12/5/2001, 12/14/2001, 12/21/2001, 1/4/2002, 1/11/2002, 1/22/2002, 1/24/2002, 2/1/2002, 2/13/2002, 2/16/2002, 2/28/2002, 3/8/2002, 3/20/2002, 3/27/2002, 4/3/2002, 4/9/2002, 4/23/2002, 5/3/2002, 5/9/2002, 5/22/2002, 6/5/2002, 6/8/2002, 6/18/2002, 6/21/2002, 6/29/2002, 7/6/2002, 7/13/2002, 7/23/2002, 7/27/2002, 8/7/2002, 8/13/2002, 8/16/2002, 8/21/2002, 8/29/2002, 9/6/2002, 9/14/2002, 9/21/2002. RECALLING FIRM/MANUFACTURER BETCO Corporation Toledo, OH, by letters on 10/1/2001. Firm initiated recall is ongoing. REASON Unapproved dye in products. VOLUME OF PRODUCT IN COMMERCE a) Antibacterial HC - 43, 225 -gals total = all pkg. sizes and configurations b) Antiseptic HC - 123,000 gals total - all pkg. sizes and configurations. DISTRIBUTION Nationwide and Japan, British Columbia. _______________________ PRODUCT Cheratussin AC Expectorant Cough Suppressant, Sugar Free containing Guaifenesin, USP (100mg/5mL), Codeine Phosphate, USP (10mg/5mL), and Alcohol, 3.5%. The product is manufactured under three names: Qualitest, Vintage, and Zenith: Goldline (Zenith Goldline uses the name, Guaituss AC Syrup, in place of Cheratussin), Recall #D-031-2. CODE Codes: QualitestÆ Lot Number Suffix NDC Numbers 012J9 A 0603-1075-56 012J9 B 0603-1075-58 012J9 C 0603-1075-56 017K9 A 0603-1075-58 018K9 A 0603-1075-58 005L9 B 0603-1075-54 005L9 C 0603-1075-56 005L9 D 0603-1075-56 006L9 A 0603-1075-58 038M9 A 0603-1075-58 039M9 A 0603-1075-56 039M9 C 0603-1075-54 039M9 D 0603-1075-54 011B0 A 0603-1075-56 012B0 A 0603-1075-60 012B0 F 0603-1075-58 003A0 B 0603-1075-58 004A0 B 0603-1075-54 004A0 C 0603-1075-56 004A0 D 0603-1075-60 023F0 B 0603-1075-54 008G0 A 0603-1075-54 008G0 B 0603-1075-60 008G0 D 0603-1075-58 012H0 C 0603-1075-58 012H0 D 0603-1075-54 012H0 E 0603-1075-58 045J0 A 0603-1075-58 046K0 A 0603-1075-58 046K0 C 0603-1075-54 046K0 D 0603-1075-56 002L0 A 0603-1075-58 016M0 A 0603-1075-58 019M0 A 0603-1075-54 019M0 C 0603-1075-58 043M0 B 0603-1075-54 043M0 C 0603-1075-56 043M0 E 0603-1075-58 024A1 D 0603-1075-58 062A1 B 0603-1075-54 062A1 C 0603-1075-56 062A1 E 0603-1075-60 062A1 F 0603-1075-56 036B1 A 0603-1075-56 036B1 C 0603-1075-58 037B1 A 0603-1075-58 059B1 A 0603-1075-58 023F1 A 0603-1075-54 027G1 A 0603-1075-54 VintageÆ Lot Number Suffix NDC Numbers 011B0 B 0254-9064-58 012B0 B 0254-9064-62 012B0 E 0254-9064-58 012B0 G 0254-9064-53 003A0 C 0254-9064-58 008G0 C 0254-9064-62 008G0 E 0254-9064-58 012H0 A 0254-9064-62 012H0 B 0254-9064-58 024A1 A 0254-9064-53 024A1 C 0254-9064-58 044D1 A 0254-9064-58 044D1 B 0254-9064-62 012F1 A 0254-9064-58 Zenith Goldline Lot Number Suffix NDC Numbers 018K9 B 0182-0017-40 005L9 A 0182-0017-37 039M9 B 0182-0017-37 011B0 C 0182-0017-40 012B0 C 0182-0017-37 012B0 D 0182-0017-40 003A0 A 0182-0017-40 004A0 A 0182-0017-37 023F0 A 0182-0017-37 046K0 B 0182-0017-37 046K0 E 0182-0017-40 043M0 A 0182-0017-37 043M0 D 0182-0017-40 024A1 B 0182-0017-37 062A1 B 0182-0017-37 036B1 B 0182-0017-40 059B1 B 0182-0017-40 007E1 A 0182-0017-37 007E1 B 0182-0017-40 RECALLING FIRM/MANUFACTURER Vintage Pharmaceuticals, Inc. Huntsville, AL, by letter dated October 1, 2001. Firm initiated recall is ongoing. REASON Subpotency (Codeine Phosphate ingredient at 12 month stability). VOLUME OF PRODUCT IN COMMERCE 15,860,150 ounces. DISTRIBUTION Nationwide and Puerto Rico. _______________________ PRODUCT Premarin Tablets (conjugated estrogen tablets USP), 1.25 mg,100 tablets per bottle, Repackaged by National PharmPak Services, Inc., Zanesville, OH, Rx only, NDC #0046-0866-81 (Wyeth-Ayerst), Recall #D-032-2. CODE Lot No. 9010249B, Exp. Date 09/03. RECALLING FIRM/MANUFACTURER Recalling Firm: National Pharmpak Services, Inc., Zanesville, OH, by letter on 8/14/2001. Manufacturer: Ayerst Laboratories, Rouses Point, NY. Firm initiated recall is ongoing. REASON Dissolution failure (by manufacturer). VOLUME OF PRODUCT IN COMMERCE 9851 bottles of 100 count. DISTRIBUTION NationwideRECALLS AND FIELD CORRECTIONS: BIOLOGICS CLASS II
_______________________ PRODUCT Corneas, Recall #B-0014-2. CODE Tissue Id. 2001-07-3073, 2001-07-3074. RECALLING FIRM/MANUFACTURER Recalling Firm: Heartland Lions Eye Banks, Columbia, MO, by telephone and letter on August 10, 2001. Procuring Firm: Missouri Lions Eye Bank, Springfield, MO. Firm initiated recall is complete. REASON Corneas, that were collected from a donor who tested repeatedly reactive for the antibody to the Hepatitis B core antigen (anti- HBc), were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION OK and KS __________________ PRODUCT Source Plasma for Manufacturing Use Only, Recall #B-0045-2. CODE Units 00LWIB8896, 00LWIB9820, 00LWIC1337, 00LWIC1965. RECALLING FIRM/MANUFACTURER Recalling Firm: Community Bio-Resources, Inc., Hoover, AL, by fax on July 25, 2000. Manufacturer: Community Bio-Resources, Inc., Onalaska, WI. Firm initiated recall is complete. REASON Blood products, collected from a donor who had not completed the CJD/nvCJD increased risk questions, were distributed. VOLUME OF PRODUCT IN COMMERCE 4 units. DISTRIBUTION Austria. _______________________ PRODUCT a) Red Blood Cells, Recall #B-0046-2; b) Platelets, Recall #B-0047-2; c) Cryoprecipitate AHF, Pooled, Recall #B-0048-2. CODE a) Unit 0546061; b) Unit 0546061; c) Unit 0546061. RECALLING FIRM/MANUFACTURER Hoxworth Blood Center, Cincinnati, Ohio, recalled by letter dated February 28, 2001. Firm initiated recall complete. REASON Blood product, collected from a donor with a history of having tested positive for hepatitis A, were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION OH. _______________________ PRODUCT a) Red Blood Cells, Recall #B-0053-2; b) Platelets, Recall #B-0054-2; c) Liquid Plasma, Recall #B-0055-2; d) Cryoprecipitate, Recall #B-0056-2; e) Recovered Plasma, Recall #B-0057-2. CODE a) Units 42FP84273, 42FY46000, 42T10971, 42S58036, 42G36643, 42J35244, 42M64574; b) Units 42FP84273, 42S58036, 42J35244, 42M64574; c) Unit 42S58036; d) Unit 42G36643; e) Units 42FP84273, 42FY46000, 42T10971, 42G36643, 42J35244. RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Cleveland, Ohio, by letter dated May 3, 2001. Firm initiated recall is complete. REASON Blood products, collected from a donor with a history of jaundice, were distributed. VOLUME OF PRODUCT IN COMMERCE 18 units. DISTRIBUTION OH and CA. __________________ PRODUCT Red Blood Cells, Leukoreduced, Recall # B-0068-2. CODE Unit F126584. RECALLING FIRM/MANUFACTURER Puget Sound Blood Center & Program, Seattle, WA, by telephone on February 13, 2001. Firm initiated recall is complete. REASON Blood product, which may not have been irradiated, was labeled as irradiated. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION WA. _______________________ PRODUCT Source Plasma, Recall #B-0083-2. CODE Units (30 units) 22428325, 19957913, 19956015, 20360887, 19669069, 14506215, 15346261, 14457166, 16636767, 16633810, 17640268, 17637268, 16314344, 16312838, 16311589, 16090507, 16088092, 16087088, YP86391, YP82372, YP82202, YP81909, YP81597, YP80442, YP80011, YP79895, YP78111, YP75686, YP75568, YP75347. RECALLING FIRM/MANUFACTURER Recalling Firm: Interstate Blood Bank, Inc., Memphis, TN, by letters dated May 17, 2000. Manufacturer: Interstate Blood Bank, Inc., Milwaukee, WI Firm initiated recall is complete. REASON Blood products, collected from a donor who had engaged in high risk behaviors, were distributed. VOLUME OF PRODUCT IN COMMERCE 30 units. DISTRIBUTION CA and IL. _______________________ PRODUCT Source Plasma, Recall # B-0084-2. CODE Units 23098244, 23092600. RECALLING FIRM/MANUFACTURER Recalling Firm: Interstate Blood Bank, Inc., Memphis, TN, by letter dated June 20, 2000. Manufacturer: Interstate Blood Bank, Inc., Madison, WI. Firm initiated recall is complete. REASON Blood products, collected from a donor who had body piercing, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION CA. _______________________ PRODUCT Source Plasma, Recall # B-0085-2. CODE 99SWIA5743, 99SWIA5935, 99SWIA6175, 99SWIA6364. RECALLING FIRM/MANUFACTURER Recalling Firm: Community Bio-Resources, Inc., Hoover, AL, by facsimile on June 1, 1999. Manufacturer: Community Bio-Resources, Inc., Sheboygan, WI. Firm initiated recall is complete. REASON Blood products, collected from a donor who had a Rubella immunization, were distributed. VOLUME OF PRODUCT IN COMMERCE 4 units. DISTRIBUTION MN. _______________________ PRODUCT a) Red Blood Cells, Leukoreduced, Recall #B-0087-2; b) Recovered Plasma, Recall # B-0088-2. CODE a) Units 21KR09340, 21KR06567; b) Units 21KR09340, 21KR06567. RECALLING FIRM/MANUFACTURER American Red Cross, Pacific Northwest Regional Blood Services, Portland, OR, by letter dated December 28, 2000. Firm initiated recall is complete. REASON Blood products, collected from a donor taking the drug Methotrexate, were distributed. VOLUME OF PRODUCT IN COMMERCE 4 units. DISTRIBUTION GA and OR. _______________________ PRODUCT a) Red Blood Cells, Leukoreduced, Recall #B-0089-2; b) Platelets, Recall #B-0090-2. CODE a) Unit 13GV13930; b) Unit 13GV13930. RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Detroit, MI, by letter dated April 19, 2001. Firm initiated recall is complete. REASON Blood products, collected from a donor who reported having lived in a country designated as endemic for malaria, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION MI. _______________________ PRODUCT a) Red Blood Cells, Recall #B-0104-2; b) Platelets Irradiated, Recall #B-0105-2; c) Recovered Plasma, Recall #B-0106-2. CODE a) Unit number 3037667; b) Unit number 3037667; c) Unit number 3037667. RECALLING FIRM/MANUFACTURER Community Blood Center, Dayton, OH, recall by letters dated April 3 and 19, 2001. Firm initiated recall is complete. REASON Blood products, collected from an ineligible donor due to medication with the drug Proscar, were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION OH and Switzerland. _______________________ PRODUCT a) Red Blood Cells, Recall #B-0107-2; b) Fresh Frozen Plasma, Recall #B-0108-2; c) Recovered Plasma, Recall #B-0109-2. CODE a) Unit numbers 06FH85173 and 06FH84102; b) Unit number 06FH85173; c) Unit number 06FH84102. RECALLING FIRM/MANUFACTURER Recalling Firm: The American National Red Cross, Los Angeles, CA, by letter dated June 18, 2000. Manufacturer: American Red Cross Blood Services, Southern California Region, Fullerton, CA. Firm initiated recall is complete. REASON Blood products, collected from an ineligible donor due to medication with the drug Methotrexate, were distributed. VOLUME OF PRODUCT IN COMMERCE 4 units. DISTRIBUTION CA. _______________________ PRODUCT a) Red Blood Cells, Recall #B-0110-2; b) Recovered Plasma, Recall #B-0111-2. CODE a) Unit number 1926993; b) Unit number 1926993. RECALLING FIRM/MANUFACTURER Central Indiana Regional Blood Center, Inc., Indianapolis, IN, recall by letter dated July 19, 2001. Firm initiated recall is complete. REASON Blood products, collected from a donor whose health history screening was inadequately performed, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION IN and Switzerland. _______________________ PRODUCT Red Blood Cells, Recall #B-0112-2. CODE Unit number 24GK22146. RECALLING FIRM/MANUFACTURER The American National Red Cross, Louisville, KY, by telephone on June 8, 2001. Firm initiated recall is complete. REASON Blood product, labeled with the incorrect red blood cell antigen typing information, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION KY. _______________________ PRODUCT a) Red Blood Cells, Leukocytes Reduced, Recall # B-0114-2; b) Recovered Plasma, Recall #B-0115-2. CODE a) Unit number FM20503; b) Unit number FM20503. RECALLING FIRM/MANUFACTURER Healthcare Provider Services, Inc., Providence, RI, recall by telephone on February 28, 2001 and by facsimile on March 1, 2001. Firm initiated recall is complete. REASON Blood products, that tested negative for antibodies to human immunodeficiency virus, types 1 and 2 (anti-HIV-1/2), but were collected from a donor that previously tested repeatedly reactive for anti-HIV-2, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION RI and Switzerland. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall #B-0116-2. CODE Unit number 12GH99665. RECALLING FIRM/MANUFACTURER The American National Red Cross, Carolinas Region, Charlotte, NC, by telephone on July 27, 2001. Firm initiated recall is complete. REASON Blood product, that tested negative for antibodies to human immunodeficiency virus, types 1 and 2 (anti-HIV-1/2), but was collected from a donor that previously tested repeatedly reactive for anti-HIV-1/2, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION NC. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-0117-2. CODE Unit number 01KK67047. RECALLING FIRM/MANUFACTURER The American National Red Cross, West Henrietta, NY, by letter dated May 1, 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 NY. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-0118-2. CODE Unit number 03GF64030. RECALLING FIRM/MANUFACTURER The American National Red Cross, Atlanta, GA 30324, by letter dated January 26, 2001. Firm initiated recall is complete. REASON Blood product, collected from an unsuitable donor based on living in an area considered endemic for malaria, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION GA. _______________________ PRODUCT Recovered Plasma, Recall # B-0121-2. CODE Unit 06GR47936. RECALLING FIRM/MANUFACTURER American Red Cross, Los Angeles, CA, by fax dated March 20, 2000. Firm initiated recall is complete. REASON Blood product, collected from a donor with a history of having tested positive for hepatitis B surface antigen (HbsAg), was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION CA. _______________________ PRODUCT Platelet, Pheresis, Leukoreduced, Recall #B-0124-2. CODE Unit 03K23318. RECALLING FIRM/MANUFACTURER American Red Cross , Atlanta, GA, by telephone on March 30, 2001 and by letter dated April 12, 2001. Firm initiated recall is complete. REASON Blood product, which was labeled as leukoreduced, but failed the quality control specification for white blood cell count, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION GA. __________________ PRODUCT Platelet, Pheresis, Leukoreduced, Recall #B-0128-2. CODE Unit 03F11943. RECALLING FIRM/MANUFACTURER American Red Cross, Atlanta, GA, by telephone on January 8, 2001 and by letter dated January 11, 2001. Firm initiated recall is complete. REASON Blood product, which was labeled as leukoreduced, but that failed the quality control specification for white blood cell count, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION GA. _______________________ PRODUCT Platelet, Pheresis, Irradiated (Split unit), Recall #B-0131-2. CODE Unit 20R12321. RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Tucson, AZ, by telephone on June 21, 2001. Firm initiated recall is complete. REASON Blood products, which were not quarantined after receiving information concerning a post nation illness, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION AZ. ____________________ PRODUCT Cornea, Recall #B-0133-2. CODE Unit C-01-172-OD. RECALLING FIRM/MANUFACTURER Lions Eye and Tissue Bank, Inc. (lions of District 22-C), Seabrook, Maryland, by telephone and by letter dated October 4, 2001. Firm initiated recall is complete. REASON Cornea, collected from a donor who tested repeat reactive for hepatitis B surface antigen (HbsAg), was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION MD. __________________ PRODUCT Fresh Frozen Plasma (3 Quad Packs), Recall #B-0145-2. CODE Unit 8798943. RECALLING FIRM/MANUFACTURER Community Blood Centers of South Florida, Lauderhill, Florida , by letter dated November 7, 1997. Firm initiated recall is complete. REASON Blood products, collected from a donor taking the drug Proscar, were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION TX. __________________ PRODUCT Platelets, Recall #B-0153-2. CODE Unit 8858283. RECALLING FIRM/MANUFACTURER Community Blood Centers of South Florida, Lauderhill, Florida, by telephone on February 25, 1998 and letter dated on or about March 6, 1998. Firm initiated recall is complete. REASON Blood product, collected from a donor with a history of ear piercing within the past 12 months, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION NY. _______________________ PRODUCT a) Red Blood Cells, Leukocytes Reduced, Recall #B-0154-2; b) Red Blood Cells, Leukocytes Reduced Irradiated, Recall #B-0155-2. CODE a) Unit numbers 18FW16936 and 18FR44026; b) Unit number 18FX23598. RECALLING FIRM/MANUFACTURER The American National Red Cross, Lansing, MI, of the recall by letters dated June 12, 2001, and July 19, 2001. Firm initiated recall is complete. REASON Blood products, collected from an unsuitable donor based on living in an area considered endemic for malaria, were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION MI. _______________________ PRODUCT Platelets Pheresis, Recall #B-0156-2. CODE Unit number 28FP04506 RECALLING FIRM/MANUFACTURER Recalling Firm: The American National Red Cross, Atlanta, GA, on or about July 22, 1998. Manufacturer: American Red Cross Blood Services, Daytona Beach, FL. Firm initiated recall is complete. REASON Blood product, that tested positive for Cytomegalovirus (CMV), but was labeled negative for CMV, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION FL. _______________________ PRODUCT a) Red Blood Cells, Leukocytes Reduced, Recall #B-0157-2; b) Plasma, Recall #B-0158-2. CODE a) Unit number 38LC14725; b) Unit number 38LC14725. RECALLING FIRM/MANUFACTURER The American National Red Cross, Fort Wayne, IN, by telephone on February 3, 2001, and by facsimile on February 7, 2001. Firm initiated recall is complete. REASON Blood products, that tested negative for the antibodies to human immunodeficiency virus, types 1 and 2 (anti-HIV-1/2), but were collected from a donor that previously tested repeatedly reactive for anti-HIV-1/2, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION IN and NY. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced Irradiated, Recall #B-0160-2. CODE Unit number 10623-0447. RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Scottsdale, AZ, by letter dated August 13, 2001. Firm initiated recall is complete. REASON Blood product, collected from an ineligible donor due to a medical history of polycythemia, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION AZ. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall #B-0161-2. CODE 18FJ43400. RECALLING FIRM/MANUFACTURER The American National Red Cross, Lansing, MI, by telephone on June 11, 2001. Firm initiated recall is complete. REASON Blood product, that was incorrectly leukoreduced, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION MI. _______________________ PRODUCT a) Red Blood Cells, Leukoreduced , Recall #B-0162-2; b) Platelets, Recall #B-0163-2. CODE Unit 01W81928; Unit 01W81928. RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, West Henrietta, NY, by telephone on October 12 and 13, 2000, and by letters dated October 23, 2000. Firm initiated recall is complete. REASON Blood products, which were mislabeled as CMV antibody negative, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION NY. _______________________ PRODUCT a) Red Blood Cells, Recall #B-0173-2; b) Red Blood Cells, Leukoreduced, Recall #B-0174-2; c) Platelets, Recall #B-0175-2; d) Recovered Plasma , Recall #B-0176-2. CODE a) Units L18895, L18879; b) Unit L25171; c) Unit L18879; d) Unit L18895. RECALLING FIRM/MANUFACTURER Central Illinois Community Blood Bank, Springfield, IL, by letters on May 21, 2001 or June 5, 2001. REASON Blood products, collected from donors whose donor history was incomplete, were distributed. VOLUME OF PRODUCT IN COMMERCE 5 units. DISTRIBUTION IL and Switzerland. _____________________ PRODUCT Source Plasma, Recall #B-0180-2. CODE Units (20 units)G-86935-118, G-86833-118, G-86182-118, G-85518- 118, G-85325-118, G-85129-118, G-84955-118, N-22054-118, N- 22029-118, G-87732-118, G-87484-118, G-87343-118, G-88101-118, G-87895-118, G-86555-118, G-86455-118, G-89151-118, G-89008-118, G-88430-118, G-88289-118. RECALLING FIRM/MANUFACTURER Recalling Firm: Alpha Therapeutic Corporation, Los Angeles, CA, by facsimile on January 24, 2001. Manufacturer: Alpha Therapeutic Corporation, Louisville, KY. Firm initiated recall is complete. REASON Blood products, which tested negative for all required viral marker testes, but were collected from a donor who had been deferred due to an unknown reactive lab result, were distributed. VOLUME OF PRODUCT IN COMMERCE 20 units. DISTRIBUTION CA, NC, Germany and Spain. _______________________ PRODUCT Source Plasma, Recall #B-0182-2. CODE G-56850-178, G-56733-178, G-56403-178, G-56104-178, G-55854-178, G-55505-178, G-55345-178, G-54976- 178, G-54853-178, G-54463-178, G-54323-178, G-53970-178, G-53805-178, G-53434-178, G-53263-178, G-52951-178, G-52755-178, G-52412-178, G-52231-178, G-51900-178, G-51734-178, G-51375-178, G-51202-178, G-50844-178, G-50668-178, G-50344-178, G-50159-178, G-49852-178, G-49511-178, G-49315-178, G-47141-178, G-46792-178, G-46626-178, G-46244-178, G-46077-178, G-45717-178, G-45570-178, G-45262-178, G-45043-178, G-44664-178, G-44489-178, G-44131-178, G-43941-178, G-43578-178, G-43403-178, G-43055-178, G-42940-178, G-42552-178, G-42376-178, G-42003-178, G-41813-178, G-41406-178, G-41218-178, G-40592-178, G-40426-178, G-40017-178, G-39883-178, G-36018-178, N-08077-178, N-08046-178. RECALLING FIRM/MANUFACTURER Seramed Bio Center/Melrose Park, Melrose Park, IL , by facsimile on February 12, 2001. Firm initiated recall is complete. REASON Blood products, which tested negative for all required tests, but were collected from a donor who had previously been deferred, were distributed. VOLUME OF PRODUCT IN COMMERCE 60 units. DISTRIBUTION CA. _______________________ PRODUCT Red Blood Cells, Recall #B-0189-2. CODE Unit 13FN62230. RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Detroit, MI, by letter dated January 25, 2001. Firm initiated recall is complete. REASON Blood product, collected from a donor taking the drug Arava, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION MI. _______________________ PRODUCT Source Plasma, Recall #B-0202-2. CODE Units 449004, 449223, 449472. RECALLING FIRM/MANUFACTURER Centeon (Aventis) Bio-Services, Inc., Little Rock, AR, by facsimile on February 21, 2000. Firm initiated recall is complete. REASON Blood products, collected from a donor with a history of having tested positive for Hepatitis B, were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION Germany. _______________________ PRODUCT Red Blood Cells, Recall #B-0218-2. CODE Unit number S84027. RECALLING FIRM/MANUFACTURER Blood Bank of San Bernadino and Riverside Counties, San Bernadino, CA, by letter dated March 21, 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 CA. ____________________ PRODUCT Red Blood Cells, Recall #B-0219-2. CODE Unit Y62482. RECALLING FIRM/MANUFACTURER Blood Bank of San Bernadino and Riverside Counties, San Bernadino, CA, by letter dated February 27, 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 CA. ___________________ PRODUCT a) Red Blood Cells, Recall #B-0220-2; b) Red Blood Cells, Leukocytes Reduced, Recall #B-0221-2. CODE a) Unit number S94694; b) Unit number S91538. RECALLING FIRM/MANUFACTURER Blood Bank of San Bernadino and Riverside Counties, San Bernadino, CA, by letters dated May 9 and 15, 2001. Firm initiated recall is complete. REASON Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION CA. ________________ PRODUCT Platelets Pheresis, Leukocytes Reduced , Recall #B-0222-2. CODE Unit numbers 2302873, 2303388, and 2303510 (distributed as two split units). RECALLING FIRM/MANUFACTURER LifeShare, Inc., Elyria, OH, by letter dated August 8, 2001. Firm initiated recall is complete. REASON Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed. VOLUME OF PRODUCT IN COMMERCE 4 units. DISTRIBUTION OH. __________________ PRODUCT Cryoprecipitated AHF, Recall #B-0223-2. CODE Unit numbers 1784941, 1750496, 1789656, 1785016, 1753225, 1786413, 1757077, 1791911, 1784507, and 1795364. RECALLING FIRM/MANUFACTURER Central Kentucky Blood Center, Inc., Lexington, KY, by letter dated June 20, 2001. Firm initiated recall is complete. REASON Blood products, which were thawed and labeled with the incorrect expiration date, were distributed. VOLUME OF PRODUCT IN COMMERCE 10 units. DISTRIBUTION KY. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall #B-0224-2. CODE Unit number 084FT33620. RECALLING FIRM/MANUFACTURER The American National Red Cross, Oakland, CA, recall by telephone on December 1, 2000, and by letter dated December 13, 2000. Firm initiated recall is complete. REASON Blood product, labeled with the incorrect expiration date, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION CA. _______________________ PRODUCT Red Blood Cells, Leukocytes, Recall #B-0248-2. CODE Reduced, Units 10623-7690 and 10633-6050. RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by letter on February 20, 2001. Manufacturer: Blood Systems, Inc., Scottsdale, AZ. Firm initiated recall is complete. REASON Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION AZ. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall #B-0249-2. CODE Unit number 8338045. RECALLING FIRM/MANUFACTURER South Florida Blood Banks, Inc., West Palm Beach, FL, by telephone on September 4, 2001. REASON Blood product, collected from an ineligible donor due to medication with the drug Proscar, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION FL. _______________________ PRODUCT Platelet Pheresis, Recall #B-0252-2. CODE Unit 6651906 (part 1). RECALLING FIRM/MANUFACTURER Suncoast Communities Blood Bank, Sarasota, FL, by telephone on September 10, 2000, and by letter dated October 2, 2000. Firm initiated recall is complete. REASON Blood product, which did not meet acceptable platelet yields, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION FL. _______________________ PRODUCT Red Blood Cells, Recall #B-0254-2. CODE Unit FM37567. RECALLING FIRM/MANUFACTURER Healthcare Provider Services, Inc., Providence, RI, by letter dated June 26, 2001. Firm initiated recall is complete. REASON Blood product, which was collected from a donor whose hemoglobin result was not documented, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION RI. _______________________ PRODUCT Red Blood Cells, Recall #B-0255-2. CODE Unit FJ83066. RECALLING FIRM/MANUFACTURER Healthcare Provider Services, Inc., Providence, RI, by letter dated July 29, 2001. REASON Blood product, which was collected from a donor whose hemoglobin result was not documented, was distributed. Firm initiated recall is complete. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION RI.RECALLS AND FIELD CORRECTIONS: BIOLOGICS CLASS III
_______________________ PRODUCT a) Red Blood Cells, Recall # B-0049-2; b) Red Blood Cells, Leukoreduced, #B-0050-2 ; c) Fresh Frozen Plasma, #B-0051-2; d) Recovered Plasma, #B-0052-2. CODE a) Units L22326, L21241; b) Units L22735, L28611; c) Units L21241, L22735; d) Units L28611, L22326. RECALLING FIRM/MANUFACTURER Central Illinois Community Blood Bank, Springfield, IL, by letter dated May 21, 2001 or July 11, 2001. 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 8 units. DISTRIBUTION IL and Switzerland. _______________________ PRODUCT Platelets Pheresis, Recall # B-0060-2. CODE Unit numbers 8837250, 8837252, 8837247. RECALLING FIRM/MANUFACTURER Community Blood Centers of South Florida, Inc., Lauderhill, FL, by letter on or about April 10, 1998. Firm initiated recall is complete. REASON Unlicensed blood PRODUCTs were distributed interstate. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION TN. _______________________ PRODUCT Source Plasma, Recall #B-0086-2. CODE 99SWIA6837, 99SWIA7074, 99SWIA7302. RECALLING FIRM/MANUFACTURER Recalling Firm: Community Bio-Resources, Inc., Hoover, AL 35244, by facsimile on June 1, 1999. Manufacturer: Community Bio-Resources, Inc. Sheboygan, WI. Firm initiated recall is complete. REASON Blood products, collected from a donor who had a Rubella immunization, were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION MN. _______________________ PRODUCT Red Blood Cells, Leukoreduced, Recall #B-0095-2. CODE Unit 3038862. RECALLING FIRM/MANUFACTURER Community Blood Center, Inc., Appleton, WI, by telephone on February 2, 2001, and by letter dated February 2, 2001. Firm initiated recall is complete. REASON Blood product, leukoreduced by filtration greater than five days past the time of collection, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION WI. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced Irradiated, Recall # B-0113-2. CODE Unit numbers 50C14091 and 50C14281. RECALLING FIRM/MANUFACTURER The American National Red Cross, Toledo, OH, by telephone on June 6, 2001, and by letter dated June 7, 2001. Firm initiated recall is complete. REASON Blood products, labeled with the incorrect expiration date, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION OH. _______________________ PRODUCT Red Blood Cells, Leukoreduced, Irradiated, Recall #B-0130-2. CODE Units 5343971, 7520291. RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, Texas by letter dated June 4, 2001. Firm initiated recall is complete. REASON Blood products, which were out of controlled storage for more than thirty minutes, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION TX. _______________________ PRODUCT Red Blood Cells, Leukoreduced, Irradiated, Recall #B-0132-2. CODE Units 50LH21552, 50LH21554. RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Toledo, OH, by telephone on June 11, and by letter dated June 14, 2001. Firm initiated recall is complete. REASON Blood products, which were labeled with the incorrect expiration date, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION OH. _______________________ PRODUCT Fresh Frozen Plasma, Recall #B-0146-2. CODE Unit 38FE72836. RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Fort Wayne, IN 46825, by telephone on July 17, 2001 and by letter dated July 18, 2001. Firm initiated recall is complete. REASON Blood product, collected from a donor whose arm inspection was not documented, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION IN. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced Washed, Recall # B-0159-2. CODE 03LR61195, 03GR54968, 03FJ63453, 03R14614, 03G10178, 03FQ16784, 03GK56226, 03L17515, 03S07957, 03FJ63332, 03FR47438, 03GJ67133, 03LL13888, 03GL52824, 03FQ16679, 03GH48291, 03V17818, 03GL54004, 03FR46726, 03GF64091, and 03FJ62453. RECALLING FIRM/MANUFACTURER The American National Red Cross, Atlanta, GA, recall by letters dated November 27, 2000, and December 27, 2000. REASON Blood products, that were below the minimum specification for red blood cell recovery, were distributed. VOLUME OF PRODUCT IN COMMERCE 21 units. DISTRIBUTION GA. _______________________ PRODUCT a) Red Blood Cells, Recall #B-0203-2; b) Platelets, Recall #B-0204-2; c) Recovered Plasma, Recall #B-0205-2. CODE a) Units 42FT85123, 42G21060; b) Unit 42T85123; c) Units 42FT85123, 42G21060. RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Cleveland, OH, by letters dated July 13, 2001. Firm initiated recall is complete. REASON Blood products, collected from a donor with a history of Idiopathic Thrombocytopenic Purpura, were distributed. VOLUME OF PRODUCT IN COMMERCE 5 units. DISTRIBUTION OH and MI. _______________________ PRODUCT a) Red Blood Cells, Leukoreduced, Recall # B-0207-2; b) Cryoprecipitated AHF, Recall #B-0208-2; c) Recovered Plasma, Recall #B-0209-2. CODE a) Unit 10626-5833; b) Unit 10626-5833; c) Unit 10626-5833. RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by letters on December 6, 2000. Manufacturer: United Blood Services, Scottsdale, AZ 85252 Firm initiated recall is complete. REASON Blood products, collected from a donor who received a bone graft within a year of donation, were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION AZ. _______________________ PRODUCT Platelets Pheresis, Recall #B-0217-2. CODE Unit number 8894571. RECALLING FIRM/MANUFACTURER Community Blood Centers of South Florida, Inc., Lauderhill, FL, recall by telephone on July 13, 1998, and by letter on or about July 16, 1998. Firm initiated recall is complete. REASON Unlicensed blood PRODUCT was distributed interstate. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION NY. _______________________ PRODUCT Red Blood Cells, Recall #B-0250-2. CODE Unit 04Q071515. RECALLING FIRM/MANUFACTURER LifeSouth Community Blood Center, Gainesville, FL, by facsimile on July 11, 2000. Firm initiated recall is complete. REASON Blood product, which was collected from a donor who had received a tissue transplant (surgery) within one year of donation, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION FL. _______________________ PRODUCT Source Plasma, Recall #B-0251-2. CODE Units 15796929, 15795687, 15793966, 15793058, 15791238, 14560217, 14558429, 14557422, 1455756, 14554513, 14552557, 14551802, 15469496, and 15468758. RECALLING FIRM/MANUFACTURER Sera-Tec Biologicals, North Brunswick, NJ, by letter dated July 19, 1999. Firm initiated recall is complete. REASON Blood products, which were collected from a donor who was taking the medication Propecia, were distributed. VOLUME OF PRODUCT IN COMMERCE 14 units. DISTRIBUTION CA. _______________________ PRODUCT Source Plasma, Recall #B-0253-2. CODE Unit YA-114266. RECALLING FIRM/MANUFACTURER Pyramid Biological Corporation, Van Nuys, CA, by letters dated April 10 and May 18, 2001. Firm initiated recall is complete. REASON Blood product, which was collected from a donor who was not properly screened, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION NJRECALLS AND FIELD CORRECTIONS: DEVICES CLASS II
**CORRECTION** Z-0217-2 listed in the November 7, 2001 Enforcement Report, as a Class II Recall, should be listed as a Class III Recall. _______________________ PRODUCT Stryker Model No. 2500 Go Bed, Recall #Z-0266-2. CODE Serial Nos. C01001 through C03551. RECALLING FIRM/MANUFACTURER Stryker Corp., Kalamazoo, MI, by letters dated 8/23/01. REASON Side rail does not always lock in the highest position and it may drop suddenly causing injury or falls to patients or caregivers. VOLUME OF PRODUCT IN COMMERCE 201 beds DISTRIBUTION NationwideRECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE - CLASS II
_______________________ PRODUCT Red Cell, Iron Rich Homogenized, Yucca Flavored Vitamin-Iron-Mineral Supplement for all classes of horses. For Animal Use Only. NET CONTENTS: 1 GALLON. HORSE HEALTH Products, A Division of Farnam Companies, Inc. PO Box 34820, Phoenix AZ 85067-4820, Recall # V-002-2. Redglo, EQUICARE (brand), Homogenized Energy Building Liquid Multi- Vitamin Supplement for Horses. EQUICARE PRODUCTS, A Division of Farnam Companies, Inc., PO Box 34820, Phoenix, AZ, Recall # V-003-2. CODE All codes. RECALLING FIRM/MANUFACTURER Farnam Companies, Inc., Phoenix, Arizona, sent a recall letter dated March 8, 2001, to all distributors via regular first class mail. Firm initiated recall is ongoing. REASON The products contain protein material derived from bovine mammalian tissues; however, the bags are not labeled with the required BSE cautionary statement. VOLUME OF PRODUCT IN COMMERCE 14,000 to 15,000 gallons. DISTRIBUTION Nationwide.RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE - CLASS III
_______________________ PRODUCT Stemz brand Horse Liniment in 12 oz. amber glass bottles and l-gallon amber glass bottles, Recall # V-004-2. CODE Lot 1075N061, manufactured on 3/16/2001, exp. 3/16/2002. RECALLING FIRM/MANUFACTURER Jogue Inc., dba Northville Laboratory, Northville, Michigan, by telephone on August 9, 2001. Firm initiated recall is complete. REASON Manufacturing, testing, and release of product was not in conformance with CGMP's. VOLUME OF PRODUCT IN COMMERCE 41.5 gallons (187 x 12 oz. and 24 x 1-gallon). DISTRIBUTION IN, MI, OH.END OF ENFORCEMENT REPORT FOR NOVEMBER 14, 2001
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