FDA

Enforcement Report

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

 August 30, 2000                                         00-35


RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II

________ PRODUCT Liu Ma Kee brand Wet Bean Curd, in 16-ounce glass jars. Recall #F-782-0. CODE None. MANUFACTURER Shenzhen Constructive Equipment & Materials, Shenzhen, China. RECALLED BY Tai Wing Hong Importer, Inc., Brooklyn, New York, by letter dated December 15, 1999. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION Florida, New York, New Jersey, Pennsylvania, Massachusetts, Ohio, Missouri, Maryland, Texas, District of Columbia. QUANTITY 350 cases (24 jars per case) were distributed. REASON Product is an unregistered low acid canned food which may not have received appropriate heat treatment to preclude the outgrowth and toxin formation by Staphylococcus aureus. ________ PRODUCT D&G Genuine Jamaican Grape Flavored Soda, in 12-fluid ounce bottles. Recall #F-784-0. CODE None. MANUFACTURER Brooklyn Bottling Company of Milton, New York, Inc., Milton, New York. RECALLED BY Manufacturer, by telephone followed by letter dated June 28, 2000. Firm- initiated recall ongoing. DISTRIBUTION New York and Florida. QUANTITY 16,791 bottles were distributed. REASON Product contains the undeclared and uncertified color additive tartrazine (certifiable as FD&C Yellow No. 5) and it contains the unapproved color additive amaranth (formerly certifiable as FD&C Red No. 2). ________ PRODUCT Haitai Health Power Beverage in 10.58-fluid ounce plastic bottles, product of Korea. Recall #F-787-0. CODE 2000.06.10. MANUFACTURER Undetermined. RECALLED BY C. Kenneth Imports Company, Inc., Bronx, New York, by letter dated July 8, 2000. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION New York, New Jersey, Pennsylvania, Virginia, Maryland. QUANTITY 47 cases (24 bottles per case) were distributed. REASON Product contained tartrazine, an uncertified color (certifiable as FD&C Yellow No. 5) and amaranth, an unapproved color (formerly certifiable as FD&C Red No. 2.) ________ PRODUCT Cafatex brand Fresh Quick Frozen Raw, Headless Black Tiger Shrimp, size 21/25, packed in 4-pound frozen blocks. Recall #F-788-0. CODE 2281299, 2241299, 1281299, 2251299, 1251299, 1271299, 1241299, 1211299. MANUFACTURER Catafex, Cantho, Vietnam. RECALLED BY Suram Trading Company, Coral Gables, Florida, by letter mailed beginning April 14, 2000. Firm-initiated recall ongoing. DISTRIBUTION Florida and Grand Cayman Island. QUANTITY 781 cases (6/4 frozen blocks per case) were distributed. REASON Product may be contaminated with Salmonella. In addition, the product was associated with a salmonellosis and enterotoxigenic E. coli outbreak. ________ PRODUCT Celebrity Chunk Light Tuna in Water, in 66.5-ounce cans. Recall #F-789-0. CODE JZXDH C2LVA. MANUFACTURER MAR Fishing Company, Recordo Zamboanga City, Phillipines. RECALLED BY Atlanta Corporation, Elizabeth, New Jersey, by telephone on August 1-3, 2000, and letter on August 3, 2000. Firm-initiated recall ongoing. DISTRIBUTION Western United States. QUANTITY 1,450 cases (6 cans per case) were distributed. REASON Product was associated with scombroid poisoning illness. ________ PRODUCT White Wave Silk brand Chocolate Soy Beverage, in 946-ml tetra pak boxes. Recall #F-790-0. CODE UPC 0 25293 60074 4, Date Codes 7/26 and 8/16. MANUFACTURER Western Quality Food Procesors, Cedar City, Utah. RECALLED BY White Wave, Inc., Boulder, Colorado, by Fax on July 19, 2000. Firm- initiated recall ongoing. DISTRIBUTION Canada. QUANTITY 20,700 quarts were distributed. REASON Product may be contaminated with milk residue (an allergen not declared on the label) due to poor manufacturing practices.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III

________ PRODUCT RO*TEL brand Diced Tomatoes and Green Chilies, in 10-ounce cans. Recall #F-783-0. CODE Top line can code: 9_RTX289A1 Case Code: 28243X289AXA1 Label Code: 6414428243. MANUFACTURER Pacific Coast Producers, Inc., Lodi, California. RECALLED BY International Home Foods, Inc., Parsippany, New Jersey, by letter on July 24, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 1,177, 848 units were distributed. REASON A can of the product was reported to contain a large metal fragment. ________ PRODUCT Canned Tiny Shrimp, in 4-ounce metal cans under the following brand names: Bumble Bee, Orleans, Libby, and Polar. Recall #F-785-0. CODE V098T and V099T (Bumble Bee, Orleans and Libby); V099T (Polar). MANUFACTURER Bumble Bee Seafoods, Violet, Louisiana. RECALLED BY Bumble Bee Seafoods, Inc., San Diego, California, by fax on May 23, 2000. Firm-initiated recall ongoing. DISTRIBUTION California, Mississippi, Colorado, Indiana, Iowa, Michigan, Pennsylvania, Maryland, New York, Missouri, Texas, North Dakota, Tennessee, Minnesota, New Jersey, Vermont, Florida. QUANTITY 356 cartons (12 per carton) of lot V098T and 3,019 cartons of lot V099T were distributed. REASON Some cans have metal plate flaws in the can end that could result in perforation and leaking of the can, leading to spoiled product. ________ PRODUCT Hsiang Yiang brand Deer's Tail Extract for Tea, in 1/3-fluid ounce (10 ml) glass vials. Recall #F-791-0. CODE None. MANUFACTURER Chang Chun Chinese Medicines & Drugs Manufactory, China. RECALLED BY Murray International Trading Company, Inc. (also known as Maxi Int'l), Brooklyn, New York, by telephone on March 17, 1999. Completed recall resulted from visits by the New York State Department of Agriculture and Markets. DISTRIBUTION New York, Florida, Maryland. QUANTITY 30 cases (60 boxes per case) were distributed. REASON Product's label does not list alcohol as an ingredient.

RECALLS AND FIELD CORRECTIONS: COSMETICS -- CLASS II

________ PRODUCT Visible Solutions Bust and Neck Firming Gel, in 4.2 fluid ounce plastic bottles. Recall #F-786-0. CODE 9G052 and 0B086. MANUFACTURER LeGroupe Sollab - Cobourg, Inc., Quebec, Canada. RECALLED BY Delgar Division Belcam, Inc., Rouses Point, New York, by letter dated July 25, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 480 units were distributed. REASON Product is contaminated with Pseudomonas aeruginosa.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

________ PRODUCT Granulocytes-Platelets Pheresis. Recall #B-1050-0. CODE Unit Numbers: 49P45679, 49P45682, 49P45696, 49P45699, 49P45703. MANUFACTURER American Red Cross Blood Services, Tulsa, Oklahoma. RECALLED BY Manufacturer, by letter dated September 13, 1999. Firm-initiated recall complete. DISTRIBUTION Oklahoma. QUANTITY 1 unit was distributed. REASON Granulocytes, Pheresis, were distributed, labeled as Granulocytes- Platelets, Pheresis. ________ PRODUCT Red Blood Cells. Recall #B-1055-0. Unit Numbers: 12FF96806 and 12GT10633. MANUFACTURER American Red Cross Blood Services, Charlotte, North Carolina. RECALLED BY Manufacturer, by letter dated March 10, 2000. Firm-initiated recall complete. DISTRIBUTION North Carolina. QUANTITY 2 units were distributed. REASON Blood products were collected from a donor with a history of aplastic anemia. ________ PRODUCT a) Fresh Frozen Plasma; b) Plasma, Cryoreduced; c) Cryoprecipitated AHF; d) Recovered Plasma. Recall #B-1057/1060-0. CODE Unit Numbers: a) 049LJ41613; b) 049LJ42617; c) 049LJ42617; d) 049LJ40738. MANUFACTURER American Red Cross Blood Services, Waco, Texas. RECALLED BY Manufacturer, by letter dated December 7, 1999. Firm-initiated recall complete. DISTRIBUTION Texas and California. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor with a history of Multiple Sclerosis. ________ PRODUCT Red Blood Cells. Recall #B-1061-0. CODE Unit #6675607. MANUFACTURER LifeShare Blood Centers, Alexandria, Louisiana. RECALLED BY Manufacturer, by telephone on August 10, 1999, and by letter dated August 18, 1999. Firm-initiated recall complete. DISTRIBUTION Louisiana. 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) Platelets. Recall #B-1062/1063-0. CODE Unit Numbers: a) 42K20999, 42R53134, 42FY06461; b) 42K20999, 42FY06461. MANUFACTURER American Red Cross Blood Services, Cleveland, Ohio. RECALLED BY Manufacturer, by letter dated April 28, 2000. Firm-initiated recall complete. DISTRIBUTION Ohio. QUANTITY a) 3 units; b) 2 units were distributed. REASON Blood products were collected from a donor who reported travel to an area designated as endemic for malaria. ________ PRODUCT Red Blood Cells. Recall #B-1065-0. CODE Unit Numbers: 49FF39275, 49FF39278, 49FF39279, 49LH43975, 49LH43976, 49LH43982, 49LH43983. MANUFACTURER American Red Cross Blood Services, Waco, Texas. RECALLED BY Manufacturer, by telephone on January 12, 2000. Firm-initiated recall complete. DISTRIBUTION Texas. QUANTITY 7 units were distributed. REASON Blood products were mislabeled as CMV antibody negative. ________ PRODUCT Red Blood Cells. Recall #B-1068-0. CODE Unit Numbers: 18216-8943 and 18218-2386. MANUFACTURER United Blood Services, Cheyenne, Wyoming. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by letter dated February 3, 1999. Firm-initiated recall complete. DISTRIBUTION Wyoming and Texas. QUANTITY 2 units were distributed. REASON Blood products were collected from a donor who reported travel to an area designated as endemic for malaria. ________ PRODUCT Red Blood Cells, Leukocytes Reduced. Recall #B-1069-0. CODE Unit #12441-4823. MANUFACTURER United Blood Services, Albuquerque, New Mexico. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by letter dated May 10, 2000. Firm-initiated recall ongoing. DISTRIBUTION New Mexico. 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) Platelets. Recall #B-1070/1071-0. CODE Unit #20278-1994. MANUFACTURER Blood Systems, Inc., Lafayette, Louisiana. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by letters dated February 29, 2000, and April 14, 2000. Firm-initiated recall complete. DISTRIBUTION Tennessee and Mississippi. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor who reported travel to an area designated as endemic for malaria. ________ PRODUCT Red Blood Cells, Leukocytes Reduced. Recall #B-1074-0. CODE Unit #20279-4222 and 20281-2856. MANUFACTURER Blood Systems, Inc., Lafayette, Louisiana. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by letter dated April 25, 2000. Firm-initiated recall complete. DISTRIBUTION Louisiana. QUANTITY 2 units were distributed. REASON Blood products were collected from a donor who reported travel to an area designated as endemic for malaria. ________ PRODUCT Platelets. Recall #B-1075-0. CODE Unit #20279-8852. MANUFACTURER Blood Systems, Inc., Lafayette, Louisiana. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by telephone on February 25, 2000. Firm-initiated recall complete. DISTRIBUTION Louisiana. 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) Platelets; b) Source Leukocytes. Recall #B-1081/1082-0. CODE Unit #3587130. MANUFACTURER Gulf Coast Regional Blood Center, Houston, Texas. RECALLED BY Manufacturer, by telephone and fax on May 20, 1999. Firm-initiated recall complete. DISTRIBUTION Texas and New Jersey. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor whose recorded body temperature was questionable. ________ PRODUCT Red Blood Cells. Recall #B-1083-0. CODE Unit #FJ27348. MANUFACTURER Healthcare Provider Services, Inc., doing business as Rhode Island Blood Center, Providence, Rhode Island. RECALLED BY Manufacturer, by telephone on August 8, 2000. Firm-initiated recall complete. DISTRIBUTION Rhode Island. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor whose hemoglobin had not been documented. ________ PRODUCT Platelets, Pheresis. Recall #B-1084-0. CODE Unit #7484645. MANUFACTURER Carter Blood Center, Bedford, Texas. RECALLED BY Manufacturer, by letter dated February 24, 2000. Firm-initiated recall complete. DISTRIBUTION Texas. QUANTITY 1 unit was distributed. REASON Blood product was collected in a manner that may have compromised the sterility of the unit. ________ PRODUCT a) Red Blood Cells; b) Red Blood Cells, Pheresis; c) Cryoprecipitated AHF; d) Fresh Frozen Plasma; e) Recovered Plasma. Recall #B-1086/1090-0. CODE Unit Numbers: a) 15005-8329; b) 15007-5146 (two split units); c) 15005- 8329; d) 15005-4631; e) 15005-8329. MANUFACTURER Blood Systems, Inc., Midland, Texas. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by letter dated March 16, 2000, and by telephone on March 1, 2000. Firm-initiated recall complete. DISTRIBUTION Texas and California. QUANTITY a) 1 unit; b) 2 split units; c) 1 unit; d) 1 unit; e) 1 unit. REASON Blood products were collected from a donor with a history of having tested positive for hepatitis. ________ PRODUCT a) Red Blood Cells; b) Cryoprecipitated AHF; c) Recovered Plasma. Recall #B-1091/1093-0. CODE Unit Numbers: a) 15005-4368, 15006-6847; b) 15005-4368; c) 15005-4368. MANUFACTURER Blood Systems, Inc., Midland, Texas. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by telephone on December 21, 1999, and by letter dated January 2, 2000. Firm-initiated recall complete. DISTRIBUTION Texas and California. QUANTITY a) 2 units; b) 1 unit; c) 1 unit distributed. REASON Blood products were collected from a donor with a history of having tested positive for hepatitis. ________ PRODUCT Components and Distribution Information System (CDIS) Stand Alone Blood Bank Software. Recall #B-1094-0. CODE All versions up to and including version 1.1.1. MANUFACTURER Information Data Management, Inc., Rosemont, Illinois. RECALLED BY Manufacturer, by telephone on July 5 and 6, 2000, and by letters dated July 7, 11, and 17, 2000. Firm-initiated recall ongoing. DISTRIBUTION South Carolina, Hawaii, Ohio, Indiana, New Jersey, Missouri, Illinois, Tennessee, Hong Kong, and the United Kingdom. QUANTITY Installed in 10 centers. REASON Blood bank software contains a defect that results in not all products produced from a donation receiving the special donation properties that are applicable to donation. ________ PRODUCT Recovered Plasma. Recall #B-1095-0. CODE Unit #4449701. MANUFACTURER Suncoast Communities Blood Bank, Inc., (Sarasota Community Blood Blood Bank, Inc., Sarasota, Florida. RECALLED BY Manufacturer, by telephone and letter on January 4, 1996. Firm-initiated recall complete. DISTRIBUTION Florida. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who had a tattoo within 12 months of donation. ________ PRODUCT Platelets. Recall #B-1096-0. CODE Unit #4455230. MANUFACTURER Suncoast Communities Blood Bank, Inc., (Sarasota Community Blood Bank, Inc.), Sarasota, Florida. RECALLED BY Manufacturer, by letter dated January 13, 1997. Firm-initiated recall complete. DISTRIBUTION Florida. 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, Apheresis (Bag 1). Recall #B-1101-0. CODE Unit #4474320. MANUFACTURER Suncoast Communities Blood Bank, Inc., Sarasota Community Blood Bank, Inc.), Sarasota, Florida. RECALLED BY Manufacturer, by telephone on February 11, 1999. Firm-initiated recall complete. DISTRIBUTION Florida. QUANTITY 1 unit was distributed. REASON Blood product had a hematocrit that was below the acceptable level. _______ UPDATE Recall #B-865/867-0, Red Blood Cells; Platelets; and Recovered Plasma (American Red Cross Blood Services, Nashville, Tennessee) which appeared in the July 12, 2000 Enforcement Report should read: CODE: Unit #19GF72679.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

________ PRODUCT a) Cocklebur Allergenic Extract; b) Rough Pigweed Allergenic Extract; c) Yellow Dock Allergenic Extract; d) Lambs Quarter Allergenic Extract. Recall #B-1051/1054-0. CODE Lot Numbers: a) A907091A; b) A906111A; c) A003242A; d) A805072B. MANUFACTURER Allergy Laboratories of Ohio, Inc., Columbus, Ohio. RECALLED BY Manufacturer, by telephone and fax on June 16, 2000. Firm-initiated recall complete. DISTRIBUTION New York. QUANTITY 1 30-ml vial of each component was distributed. REASON Expiration dates were omitted from the labeling of four allergenic extracts. ________ PRODUCT Source Plasma. Recall #B-1056-0. CODE Unit Numbers: 1941V045A and 1941V140A. MANUFACTURER Centeon Bio-Services, Inc., Fort Worth, Texas. RECALLED BY Manufacturer, by letter dated April 6, 1999. Firm-initiated recall complete. DISTRIBUTION Germany. QUANTITY 1 unit was distributed. REASON Blood products were collected from a donor who had previously been deferred for a history of Lupus. ________ PRODUCT Red Blood Cells, Leukocytes Reduced. Recall #B-1066-0. CODE Unit Numbers: 11324-7452, 11324-7478, 11324-7488, 11324-7821, 11324-7828, 11324-7810. MANUFACTURER Blood Systems, Inc., El Paso, Texas. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by, telephone on February 29, 2000, and by letters dated March 29, 2000. Firm-initiated recall complete. DISTRIBUTION Texas and New Mexico. QUANTITY 6 units were distributed. REASON Blood products were stored at unacceptable temperatures. ________ PRODUCT Platelets. Recall #B-1067-0. CODE Unit #11323-3909. MANUFACTURER Blood Systems, Inc., El Paso, Texas. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by telephone on November 17, 1999. Firm-initiated recall complete. DISTRIBUTION Texas. QUANTITY 1 unit was distributed. REASON Blood product was prepared from a whole blood unit that had discrepant start and end times documented. ________ PRODUCT Platelets. Recall #B-1072-0. CODE Unit #7719234. MANUFACTURER Carter Blood Center, Bedford, Texas. RECALLED BY Manufacturer, by letter dated February 29, 2000. Firm-initiated recall complete. DISTRIBUTION Texas. QUANTITY 1 unit was distributed. REASON Blood product was prepared from a whole blood unit that had discrepant start and end times documented. ________ PRODUCT Platelets. Recall #B-1073-0. CODE Unit #7727484. MANUFACTURER Carter Blood Center, Bedford, Texas. RECALLED BY Manufacturer, by letter dated March 14, 2000. Firm-initiated recall complete. DISTRIBUTION Texas. QUANTITY 1 unit was distributed. REASON Blood product was prepared from a whole blood unit that had discrepant start and end times documented. _________ PRODUCT Red Blood Cells, Leukoreduced. Recall #B-1076-0. CODE Unit #11323-5196. MANUFACTURER United Blood Services, El Paso, Texas. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by telephone on November 17, 1999. Firm-initiated recall complete. DISTRIBUTION Texas. QUANTITY 1 unit was distributed. REASON Blood product failed the criteria for red blood cell recovery after leukoreduction. ________ PRODUCT Red Blood Cells. Recall #B-1077-0. CODE Unit #49J80373. MANUFACTURER American Red Cross Blood Services, Tulsa, Oklahoma. RECALLED BY Manufacturer, by telephone on August 23, 1999. Firm-initiated recall complete. DISTRIBUTION Oklahoma. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor whose arm inspection was not documented as being performed. ________ PRODUCT Platelets. Recall #B-1078-0. CODE Unit #D98-03178. MANUFACTURER Beth Israel Deaconess Hospital, Boston, Massachusetts. RECALLED BY Manufacturer, by letter dated June 1, 1999. Firm-initiated recall complete. DISTRIBUTION Massachusetts. QUANTITY 1 unit was distributed. REASON Blood product tested repeatedly reactive for HBsAg, confirmatory negative, and negative for anti-HBc. ________ PRODUCT Platelets. Recall #B-1079-0. CODE Unit #7694303. MANUFACTURER Carter Blood Center, Bedford, Texas. RECALLED BY Manufacturer, by letter dated February 7, 2000. Firm-initiated recall complete. DISTRIBUTION Texas. QUANTITY 1 unit was distributed. REASON Blood product was prepared from a whole blood unit that had discrepant start and end times documented. ________ PRODUCT Platelets. Recall #B-1080-0. CODE Unit #7738904. MANUFACTURER Carter Blood Center, Bedford, Texas. RECALLED BY Manufacturer, by letter dated May 2, 2000. Firm-initiated recall complete. DISTRIBUTION Texas. QUANTITY 1 unit was distributed. REASON Blood product was prepared from a whole blood unit that had discrepant start and end times documented. ________ PRODUCT Red Blood Cells, Leukocytes Reduced. Recall #B-1097-0. CODE Unit #12438-6614. MANUFACTURER United Blood Services, Albuquerque, New Mexico. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by telephone on July 9, 1999. Firm-initiated recall complete. DISTRIBUTION New Mexico. QUANTITY 1 unit was distributed. REASON Blood product was labeled with an extended expiration date.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

________ UPDATE Recall #Z-842/845-0, Medtronic Midas Rex Dissecting Tool: M-1, AM-3, S4-350, and S8-3500, which appeared in the July 5, 2000 Enforcement Report has been changed to a Class II recall.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III

________ PRODUCT DMA Bilirubin Calibrator, in-vitro diagnostic used as a standard for in- vitro assays of serum total and direct bilirubin: a) Level 1, Catalog #241-151; b) Level 2, Catalog #241-152. Recall #Z-908/909-0. CODE a) Lot #RC22 EXP 10/30/00; b) Lot #RC96 EXP 08/30/00. MANUFACTURER Data Medical Associates, Inc., Arlington, Texas. RECALLED BY Manufacturer, by letters dated May 16 and 23, 2000. Firm-initiated recall ongoing. DISTRIBUTION Kentucky, Ohio, Tennessee, Missouri, Florida, Louisiana, California, Mexico, Poland, Sri Lanka, India, Venezuela, Panama. QUANTITY a) 327 vials; b) 131 vials were distributed. REASON Some vials of product were producing out of range assay results.

RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS - - CLASS II

________ PRODUCT Vedco brand NFZ Puffer (contains nitrofurazone), in 1.50-ounce bottle. Recall #V-102-0. CODE Lot Numbers: 06975, 07257, 07468, 07469, and 07517. MANUFACTURER Hess & Clark, Inc., Ashland, Ohio. RECALLED BY Manufacturer, by letter dated February 23, 2000. Firm-initiated recall complete. DISTRIBUTION Missouri. QUANTITY 899 cases (12 bottles per case) were distributed. REASON Product is approved only for use on dogs, cats and horses. NADA 11-154. Product is labeled for pink eye in cattle , sheep and goats.
END OF ENFORCEMENT REPORT FOR AUGUST 30, 2000.
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