October 25, 2000 00-43RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
________ PRODUCT D&G Genuine Grapefruit Flavored Soda, in 12-fluid ounce bottles. Recall #F-005-1. CODE None. All product on the market at time of recall initiation. MANUFACTURER Brooklyn Bottling Company of Milton, NY Inc., Milton, New York. RECALLED BY Manufacturer, by letter dated August 22, 2000. Firm-initiated recall ongoing. DISTRIBUTION New York and Florida. QUANTITY 5,799 cases (24 bottles per case) were distributed. REASON Product contains the undeclared and uncertified color additive tartrazine (certifiable as FD&C Yellow No. 5). ________ PRODUCT Custom Food Group Sandwiches, sold in vending machines: a) Catfish Po-Boy Sandwich, 8 ounces; b) Chicken Fried Steak on a Bun Sandwich, 6.5 ounces. Recall #F-007/008-1. CODE a) Lot #A0919; b) A0920. MANUFCTURER Custom Food Group, Dallas, Texas. RECALLED BY Manufacturer, by letter on September 21, 2000. Firm-initiated recall complete. DISTRIBUTION Texas. QUANTITY a) 195 units; b) 890 units were distributed. REASON Products contained undeclared FD&C Yellow No. 5. ________ PRODUCT Ultra Slim-Fast Ready-To-Drink Milk-Based Shakes, a meal replacement beverage in 11 ounce cans: a) Strawberries'N Cream; b) Creamy Milk Chocolate; c) Cappuccino Delight. Recall #F-009/011-1. CODE Code Flavor Packaging ETAS 0125 E Strawberries ‘N Cream 6 pack only ETMC 0125 E Creamy Milk Chocolate 6 pack only ETCD 0138 E Cappuccino Delight 6 pack only ETMC 0138 E Creamy Milk Chocolate 6 pack only ETAS 0140 E Strawberries ‘N Cream 6 & 8 pack only ETAS 0141 E Strawberries ‘N Cream 6 pack only ETCD 0142 E Cappuccino Delight 6 pack only ETMC 0142 E Creamy Milk Chocolate 8 pack only. MANUFACTURER Slim-Fast Nutritional Foods, LLC, Covington, Tennessee. RECALLED BY Slim-Fast Foods, New York, New York, by telephone July 12 and 17, 2000, followed by letter on July 21, 2000, and by press release on August 3, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and Mexico. QUANTITY 2,103,765 cans were distributed. REASON Product may have been re-contaminated after it was thermally processed.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
_______ PRODUCT Illumine (tm) 30 Minute in-Office Tooth Whitener, 30% Hydrogen Peroxide. Recall #D-002-1. CODE Catalog #614037P (20 pack) and 614037 (10 pack); Lot Numbers: 1229, 1234, 1240, 1241, 1251, 1253, 1254, 1255, 1259, 1259A, 1262, and 1280. MANUFACTURER Dentsply Preventive Care, York, Pennsylvania. RECALLED BY Manufacturer, by telephone on September 18, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide, Mexico, Germany, Argentina, Brazil, Australia, Japan, Hong Kong. QUANTITY 100,408 syringes (1,210 20-packs and 180 10-packs) were distributed. REASON Defective coupling valve (stopcock) resulting in the forceful ejection of contents.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
________ PRODUCT Iopamidol-300 (Iopamidol Injection, USP) 61%, 150 mL in a 200 mL vial, Single Dose, Rx for intravascular use for angiography throughout the cardiovascular system and intravenous adult and pediatric contrast enhancement of computed tomographic head and body imaging. NDC #63323-803-60. Recall #D-001-1. CODE Lot Numbers: 100119 EXP 02/02 and 100393 EXP 05/02. MANUFACTURER American Pharmaceutical Partners, Inc., Melrose Park, Illinois. RECALLED BY Manufacturer, by letter dated September 21, 2000. Firm-initiated recall ongoing. DISTRIBUTION California and Virginia. QUANTITY 7,800 vials were distributed; firm estimated that 10 percent of product remained on market at time of recall initiation. REASON Lack of efficacy.RECALLS AND FIELD CORRETIONS: BIOLOGICS -- CLASS II
________ PRODUCT Red Blood Cells. Recall #B-011-1. CODE Unit #110-9262. MANUFACTURER General Hospital Corporation, doing business as Massachusetts General Hospital, Boston, Massachusetts. RECALLED BY Manufacturer, by letter dated June 16, 2000. Firm-initiated recall complete. DISTRIBUTION Massachusetts. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who reported travel to an area designated as endemic for malaria. ________ PRODUCT Source Plasma. Recall #B-024-1. CODE Unit Numbers: 99MWIA9375, 99MWIA9868, 99MWIB0555, 99MWIB1520, 99MWIB4275, 99MWIB4905, 99MWIB2177, 99MWIB2602, and 99MWIB3456. MANUFACTURER Community Bio-Resources, Inc., Menasha, Wisconsin. RECALLED BY Manufacturer, by letter dated April 28, 1999. Firm-initiated recall complete. DISTRIBUTION Michigan and Austria. QUANTITY 9 units were distributed. REASON Blood products were collected from a donor who reported an accidental blood exposure. ________ PRODUCT a) Red Blood Cells; b) Recovered Plasma. Recall #B-036/037-1. CODE Unit #GV02665. MANUFACTURER Central Blood Bank, Pittsburgh, Pennsylvania. RECALLED BY Manufacturer, a) by telephone on June 28, 1999, followed by fax on July 16, 1999; b) by fax on June 11, 1999. Firm-initiated recall complete. DISTRIBUTION Pennsylvania and Switzerland. QUANTITY 1 unit of each component was distributed. REASON Blood products were incorrectly tested for the hepatitis B surface antigen (HBsAg). ________ PRODUCT a) Red Blood Cells; b) Red Blood Cells, Irradiated; c) Platelets; d) Platelets, Irradiated; e) Cryoprecipitated AHF; f) Source Leukocytes. Recall #B-041/046-1. CODE Unit Numbers: a) 18GH27895, 18GH09690; b) 18GG14050, 18GG12514; c) 18GH09690; d) 18GG12514; e) 18GH27895; f) 18GG14050. MANUFACTURER American Red Cross Blood Services, Lansing, Michigan. RECALLED BY Manufacturer, by letters dated April 10, 13, or 15, 1998, and May 19, 1998. Firm-initiated recall complete. DISTRIBUTION Michigan, Ohio, New Jersey, California. QUANTITY a) 2 units; b) 2 units; c) 1 unit; d) 1 unit; e) 1 unit; f) 1 unit. REASON Blood products were collected from a donor who was taking the drug, Methotrexate. ________ PRODUCT Platelets, Pheresis, Leukocytes Reduced. Recall #B-048-1. CODE Component Code 12750; Unit #17FX27543. MANUFACTURER American Red Cross Blood Services, North Central Blood Services, St. Paul, Minnesota. RECALLED BY Manufacturer, by letter dated June 19, 2000. Firm-initiated recall complete. DISTRIBUTION Minnesota. QUANTITY 1 unit was distributed. REASON The first half of a split Platelet, Pheresis unit was found to be contaminated with coagulase negative Staphylococci. The second half of the unit had been distributed. ________ PRODUCT a) Red Blood Cells; b) Recovered Plasma. Recall #B-079/080-1. CODE Unit #FL06548. MANUFACTURER Central Illinois Community Blood Bank, Springfield, Illinois. RECALLED BY Manufacturer, by telephone or fax on June 14, 2000. Firm-initiated recall complete. DISTRIBUTION Illinois and Switzerland. QUANTITY 1 unit of each component was distributed. REASON Blood products tested negative for anti-HIV 1/2, Western blot indeterminate. ________ PRODUCT Platelets, Pheresis. Recall #B-081-1. CODE Unit Numbers: 0057202, 15-0050503, 15-0050711, 15-0054275, 13-0062404, 15-0060786, 15-0060996, 15-0067237. MANUFACTURER United Blood Services, Midland, Texas. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by telephone and letters on January 4, 2000, and February 22, 2000. Firm-initiated recall complete. DISTRIBUTION Texas. QUANTITY 8 units were distributed. REASON Blood products were collected from a donor taking the drug, Asacol for colitis. ________ PRODUCT Platelets, Pheresis, Leukoreduced. Recall #B-082-1. CODE Unit #15-0060020. MANUFACTURER Blood Systems, Inc., Texas Blood Institute, Lubbock Center, Lubbock, Texas. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by telephone on July 15, 1999. Firm-initiated recall complete. DISTRIBUTION Texas. QUANTITY 1 unit was distributed. REASON Blood product had an unacceptable platelet yield. ________ PRODUCT a) Red Blood Cells; b) Platelets. Recall #B-087/088-1. CODE Unit #11322-8681. MANUFACTURER Blood Systems, Inc., El Paso, Texas. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by telephone and letter on February 1, 2000. Firm-initiated recall complete. DISTRIBUTION Texas and New Mexico. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor who traveled to an area considered endemic for malaria. ________ PRODUCT Red Blood Cells. Recall #B-089-1. CODE Unit #17KC09905. MANUFACTURER American Red Cross Blood Services, North Central Blood Services, St. Paul, Minnesota. RECALLED BY Manufacturer, by letter dated February 25, 2000. Firm-initiated recall complete. DISTRIBUTION Michigan. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who reported travel to a malarial endemic area and who had an accidental blood exposure. ________ PRODUCT Platelets Pheresis, Leukocytes Reduced. Recall #B-090-1. CODE Unit #3380145. MANUFACTURER Florida Blood Services, Tampa, Florida. RECALLED BY Florida Blood Services, St. Petersburg, Florida, by fax on January 27, 1998. Firm-initiated recall complete. DISTRIBUTION Florida. QUANTITY 1 unit was distributed. REASON Blood product had a high white blood cell count. ________ PRODUCT Red Blood Cells. Recall #B-091-1. CODE Unit Numbers: 3441487, 3444401, 3153462. MANUFACTURER Florida Blood Services, St. Petersburg, Florida. RECALLED BY Manufacturer, by telephone and letters on June 12, 1997. Firm-initiated recall complete. DISTRIBUTION Florida. QUANTITY 3 units were distributed. REASON Blood products were collected from donors whose body temperature had not been documented or whose hemoglobin check was marked as unsatisfactory. ________ PRODUCT Red Blood Cells. Recall #B-092-1. CODE Unit #FS38678. MANUFACTURER Inova Health Care Services, Inova Health Care Services Blood Donor Services, Annandale, Virginia. RECALLED BY Manufacturer, by letter dated February 26, 1998. Firm-initiated recall complete. DISTRIBUTION District of Columbia. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who reported travel to an area designated as endemic for malaria. ________ PRODUCT Red Blood Cells. Recall #B-094-1. CODE Unit #38FC57767. MANUFACTURER American Red Cross Blood Services, Fort Wayne, Indiana. RECALLED BY Manufacturer, by letter on May 24, 2000. Firm-initiated recall complete. DISTRIBUTION Indiana. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who reported travel to an area designated as endemic for malaria. ________ PRODUCT Red Blood Cells. Recall #B-095-1. CODE Unit #13GV03679. MANUFACTURER American Red Cross Blood Services, Detroit, Michigan. RECALLED BY Manufacturer, by letter on October 14, 1999. Firm-initiated recall complete. DISTRIBUTION Michigan. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who reported travel to an area designated as endemic for malaria. ________ PRODUCT Red Blood Cells. Recall #B-096-1. CODE Unit #18221-5814. MANUFACTURER United Blood Services, Cheyenne, Wyoming. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by letter dated June 14, 2000. Firm-initiated recall complete. DISTRIBUTION New Jersey. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who reported travel to an area designated as endemic for malaria. ________ PRODUCT a) Red Blood Cells; b) Fresh Frozen Plasma. Recall #B-099/100-1. CODE Unit #FE35894. MANUFACTURER Inova Health Care Services, Inova Health Care Services, Annandale, Virginia. RECALLED BY Manufacturer, by letter dated July 31, 1997. Firm-initiated recall complete. DISTRIBUTION District of Columbia. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor who had a tattoo within 12 months of donation. ________ PRODUCT Platelets. Recall #B-104-1. CODE Unit #X69877. MANUFACTURER Aurora Area Blood Bank, Heartland Blood Centers, Aurora, Illinois. RECALLED BY Manufacturer, by letter dated November 18, 1999. Firm-initiated recall complete. DISTRIBUTION Indiana. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor whose body temperature had not been documented. ________ PRODUCT Platelets. Recall #B-105-1. CODE Unit #16336-7165. MANUFACTURER Blood Systems, Inc., Meridian, Mississippi. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by telephone on September 22, 1996. Firm-initiated recall complete. DISTRIBUTION Mississippi. QUANTITY 1 unit was distributed. REASON Platelets were prepared from a unit collected from a donor who had taken aspirin within three days of donation. ________ PRODUCT a) Red Blood Cells; b) Recovered Plasma. Recall #B-109/110-1. CODE Unit Numbers: a) 4172756, 5300138, 4172738, 4172793, 8956410, 2905325, 2905403, 5300686, 5300736, 5302521, 2284183, 8956034, 1759079, 4173689, 4480005, 5301835, 5303420, 4174762, 1759804, 1760707, 8955327, 4480703, 2907716; b) 4172756, 5300138, 4172738, 4172793, 8956410, 2905325, 5300686, 5300736, 5302521, 2284183, 8956034, 1759079, 4173689, 4480005, 5301835, 4174762, 1759804, 1760707, 8955327, 4480703, 2907716. MANUFACTURER Florida Georgia Blood Alliance, Inc., Jacksonville, Florida. RECALLED BY Manufacturer, by letter dated June 25, 1998. Firm-initiated recall complete. DISTRIBUTION Florida and Pennsylvania. QUANTITY a) 23 units; b) 21 units were distributed. REASON Blood products were incorrectly tested for syphilis. ________ PRODUCT Platelets, Pheresis, Leukoreduced. Recall #B-115-1. CODE Unit #41FP28444. MANUFACTURER American Red Cross Blood Services, Birmingham, Alabama. RECALLED BY Manufacturer, by letter dated July 16, 1999. Firm-initiated recall complete. DISTRIBUTION Alabama. QUANTITY 1 unit was distributed. REASON Blood product had an unacceptable platelet yield. ________ PRODUCT a) Red Blood Cells; b) Recovered Plasma. Recall #B-116/117-1. CODE Unit Numbers: 41GE27476 and 41GN21979. MANUFACTURER American Red Cross Blood Services, Birmingham, Alabama. RECALLED BY Manufacturer, by letter dated March 29, 2000, or by fax on March 28, 2000. Firm-initiated recall complete. DISTRIBUTION Alabama and California. QUANTITY 2 units of each component was distributed. REASON Blood products were collected from a donor with a history of hepatitis. ________ PRODUCT Red Blood Cells, Leukoreduced. Recall #B-118-1. CODE Unit #41GM34235. MANUFACTURER American Red Cross Blood Services, Birmingham, Alabama. RECALLED BY Manufacturer, by telephone on June 22, 1999. Firm-initiated recall complete. DISTRIBUTION Alabama. QUANTITY 1 unit was distributed. REASON Blood product had an unacceptable red blood cell recovery after leukoreduction. ________ PRODUCT Platelets, Pheresis. Recall #B-119-1. CODE Unit #41FP28285. MANUFACTURER American Red Cross Blood Services, Birmingham, Alabama. RECALLED BY Manufacturer, by letters dated May 13, 1999, and June 16, 1999. Firm- initiated recall complete. DISTRIBUTION Alabama. QUANTITY 1 unit was distributed. REASON Blood product had an unacceptable platelet yield. _______ PRODUCT a) Red Blood Cells; b) Red Blood Cells, Leukoreduced; c) Recovered Plasma. Recall #B-120/122-1. CODE a&c) Unit #41FX29256; b&c) Unit #41FW23379;. MANUFACTURER American Red Cross Blood Services, Birmingham, Alabama. RECALLED BY Manufacturer, by fax on January 29, 1999, and letter dated February 5, 1999. Firm-initiated recall complete. DISTRIBUTION Alabama and California. QUANTITY a) 1 unit; b) 1 unit; c) 2 units were distributed. REASON Blood products tested negative for anti-HCV, but were collected from a donor who previously tested initially reactive for anti-HCV with no duplicate repeat testing. ________ PRODUCT a) Red Blood Cells; b) Recovered Plasma. Recall #B-123/124-1. CODE Unit #41LX28008. MANUFACTURER American Red Cross Blood Services, Birmingham, Alabama. RECALLED BY Manufacturer, by letter dated December 17, 1998, or by fax on December 29, 1998. Firm-initiated recall complete. DISTRIBUTION Alabama and California. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor who received a tattoo within 12 months of donation. ________ PRODUCT Red Blood Cells, for further manufacture of non-injectable products. Recall #B-125-1. CODE Unit #PA04786. MANUFACTURER Interstate Blood Bank, Inc., Memphis, Tennessee. RECALLED BY Manufacturer, by telephone in November 1998, followed by letter dated December 14, 1998. Firm-initiated recall complete. DISTRIBUTION Minnesota. QUANTITY 1 unit was distributed. REASON Blood product tested repeatedly reactive for anti-HIV-1/2. _______ PRODUCT Red Blood Cells. Recall #B-127-1. CODE Unit #0901255. MANUFACTURER West Tennessee Regional Blood Center, Inc., Jackson, Tennessee. RECALLED BY Manufacturer, by telephone on June 23, 1999. Firm-initiated recall complete. DISTRIBUTION Tennessee. QUANTITY 1 unit was distributed. REASON Blood product was distributed after receiving post donation information that made the unit unsuitable for transfusion. ________ PRODUCT Red Blood Cells. Recall #B-129-1. CODE Unit #38FC47791. MANUFACTURER American Red Cross Blood Services, Fort Wayne, Indiana. RECALLED BY Manufacturer, by telephone on May 4, 1999. Firm-initiated recall complete. DISTRIBUTION Indiana. QUANTITY 1 unit was distributed. REASON Blood product was prepared from an overweight unit of whole blood.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
________ PRODUCT a) Reagent Red Blood Cells, Panoscreen I and II; b) Reagent Red Blood Cells, Panoscreen I, II, and III. Recall #B-039-1. CODE a) Lot #41764; b) Lot #41758. MANUFACTURER Immucor, Inc., Norcross, Georgia. RECALLED BY Manufacturer, by fax on October 4, 1999. Firm-initiated recall complete. DISTRIBUTION Japan and Hong Kong. QUANTITY a) 221 kits; b) 248 kits were distributed. REASON Reagent Red Blood Cells showed intermittent discoloration and microbial contamination. ________ PRODUCT Reagent Red Blood Cells, Panoscreen I, II, and III. Recall #B-040-1. CODE Lot #39718. MANUFACTURER Immucor, Inc., Norcross, Georgia. RECALLED BY Manufacturer, by fax on September 17, 1999. Firm-initiated recall complete. DISTRIBUTION Japan. QUANTITY 212 kits were distributed. REASON Reagent Red Blood Cells showed hemolysis and microbial contamination. ________ PRODUCT Source Plasma. Recall #B-058-1. CODE Unit # 98MW1B4931. MANUFACTURER Community Bio-Resources, Inc., Menasha, Wisconsin. RECALLED BY Community Bio-Resources, Inc., Hoover, Alabama, by fax on October 21, 1998. Firm-initiated recall complete. DISTRIBUTION Austria. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who had a Hepatitis B immunization one day prior to the date of donation. ________ PRODUCT a) Red Blood Cells; b) Pooled Cryoprecipitated AHF; c) Recovered Plasma. Recall #B-061/063-1. CODE Unit Numbers: a&c) Unit #17KR55494; b) Pooled Unit 736 (containing unit 17KR55494). MANUFACTURER American Red Cross Blood Services, St. Paul, Minnesota. RECALLED BY Manufacturer, by letter dated April 24, 2000, and "Questionable Plasma Inquiry" dated April 27, 2000. Firm-initiated recall complete. DISTRIBUTION Iowa, Minnesota, Switzerland. QUANTITY 1 unit and 1 pooled unit were distributed. REASON Blood products were collected from a donor with an elevated body temperature. ________ PRODUCT Fresh Frozen Plasma. Recall #B-077-1. CODE Unit #16339-0417. MANUFACTURER United Blood Services, Meridian, Mississippi. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by telephone on June 20, 1997. Firm-initiated recall complete. DISTRIBUTION Mississippi. QUANTITY 1 unit was distributed. REASON Fresh Frozen Plasma was frozen more than eight hours after whole blood collection. ________ PRODUCT Red Blood Cells, Leukoreduced, Irradiated. Recall #B-083-1. CODE Unit Numbers: 2279729 and 2279706. MANUFACTURER Florida-Georgia Blood Alliance, Jacksonville, Florida. RECALLED BY Manufacturer, by telephone on May 29, 1997. Firm-initiated recall complete. DISTRIBUTION Florida. QUANTITY 2 units were distributed. REASON Blood products were labeled with extended expiration dates. ________ PRODUCT Red Blood Cells. Recall #B-098-1. CODE Unit #FY91260. MANUFACTURER Inova Health Care Services, Inova Health Care Services Blood Donor Services, Annandale, Virginia. RECALLED BY Manufacturer, by letter dated September 20, 1997. Firm-initiated recall complete. DISTRIBUTION District of Columbia. QUANTITY 1 unit was distributed. REASON Blood product tested negative for HBsAg, but was distributed prior to completion of HBsAg. ________ PRODUCT Red Blood Cells, Leukoreduced. Recall B-102-1. CODE Unit #65-43882, 65-43684, 65-43068, 65-43680. MANUFACTURER Michigan Community Blood Centers, Grand Valley Blood Program, Grand Rapids, Michigan. RECALLED BY Manufacturer, by telephone on December 20, 1999. Firm-initiated recall complete. DISTRIBUTION Michigan. QUANTITY 4 units were distributed. REASON Blood product was labeled with an extended expiration date. ________ PRODUCT Red Blood Cells, Leukocytes Reduced. Recall #B-103-1. CODE Unit Numbers: 4962250, 2821022, 1085348, 1482203, 1436935, 2822025, 1560040. MANUFACTURER New York Blood Services (Center West), A Division of New York Blood Center, Inc., New York, New York. RECALLED BY Manufacturer, by letter dated February 16, 2000. Firm-initiated recall complete. DISTRIBUTION New York. QUANTITY 7 units were distributed. REASON Blood products were leukoreduced using expired filters. ________ PRODUCT a) Red Blood Cells; b) Fresh Frozen Plasma. Recall #B-111/112-1. CODE Unit #2911304. MANUFACTURER Florida Georgia Blood Alliance, Inc., Jacksonville, Florida. RECALLED BY Manufacturer, by telephone on December 21, 1998. Firm-initiated recall complete. DISTRIBUTION Florida and Georgia. QUANTITY 1 unit was distributed. REASON Blood products were collected from a donor whose arm inspection was not documented as being performed. ________ PRODUCT Red Blood Cells, Leukoreduced. Recall #B-113-1. CODE Unit #8959784. MANUFACTURER Florida Georgia Blood Alliance, Inc., Jacksonville, Florida. RECALLED BY Manufacturer, by telephone on November 25, 1998. Firm-initiated recall complete. DISTRIBUTION Florida. QUANTITY 1 unit was distributed. REASON Blood product was leukoreduced greater than five days after the collection date. ________ PRODUCT Red Blood Cells. Recall #B-114-1. CODE Unit #4183630. MANUFACTURER Florida Georgia Blood Alliance, Inc., Jacksonville, Florida. RECALLED BY Manufacturer, by telephone on January 20, 1999. Firm-initiated recall complete. DISTRIBUTION Florida. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who was taking the drug Propecia. ________ PRODUCT Red Blood Cells, Leukoreduced. Recall #B-128-1. CODE Unit #0903930. MANUFACTURER West Tennessee Regional Blood Center, Inc., Jackson, Tennessee. RECALLED BY Manufacturer, by telephone on January 13, 2000. Firm-initiated recall complete. DISTRIBUTION Tennessee. QUANTITY 1 unit was distributed. REASON Blood product was labeled with an extended expiration date. END OF ENFORCEMENT REPORT FOR OCTOBER 25, 2000.####
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