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.


October 18, 2000                                                                                                          
00-42

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I

________ PRODUCT Badia brand Paprika, in 2-ounce bottles. Recall #F-006-1. CODE Expiration date of "11/02". REPACKER Badia Spices, Inc., Miami, Florida. RECALLED BY Repacker, by telephone and visit beginning July 14, 2000, by letter on August 30, 2000. Ongoing recall resulted from sample analysis and follow- up by the Florida Department of Agriculture. DISTRIBUTION Florida, Georgia, Louisiana, Texas, New York, Massachusetts, Maryland, Puerto Rico, Colombia, Peru, West Indies. QUANTITY 22,860 bottles were distributed. REASON Product is contaminated with Salmonella.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II

________ PRODUCT Pillsbury Wheat Bread, 24 ounces. Recall #F-004-1. CODE UPC Code 1800 66206. Lot Numbers: SEP25D222610921, SEP25E222610921, SEP25F222610921, SEP25G222610921, SEP26D222620922, SEP26E222620922, SEP26F222620922, SEP26G222620922. MANUFACTURER Interstate Brands West Corporation/Millbrook Bakery, Glendale, California. RECALLED BY Interstate Brands West Corporation, Kansas City, Missouri, by alerting stores on September 20, 2000. Firm-initiated recall complete. DISTRIBUTION Nevada. QUANTITY 484 loaves were distributed and all product has been accounted for. REASON PRODUCT contained undeclared soy ingredients.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III

________ PRODUCT Garden Goodness Thousand Island Salad Dressing, in 16-ounce glass bottles. Recall #F-002-1. CODE Use By Date 7/12/01 and 7/13/01. Lots 07/12/01 7, 07/12/01 8, 07/12/01 9, 07/12/01 10, 07/12/01 11, 07/13/01 14, 07/13/01 15, 07/13/01 16, 07/13/01/ 17, 07/13/01 18, 07/13/01 19, and 07/13/01 20. MANUFACTURER North Coast Processing, North East, Pennsylvania. RECALLED BY Manufacturer, by telephone on August 10, 2000, and by letter on August 14, 2000. Firm-initiated recall ongoing. DISTRIBUTION California, North Carolina, New York, Ohio, Pennsylvania, Tennessee, Virginia. QUANTITY 26,046 bottles were distributed. REASON Product is contaminated with yeast. ______ PRODUCT Suzanne's brand Sensational Raspberry Walnut Dressing & Marinade in 12- fluid ounce glass bottles. Recall #F-003-1. CODE MWFRV00167C. MANUFACTURER Mad Will's Food Company, Inc., Auburn, California. RECALLED BY Manufacturer, by letter on August 21, 2000, followed by telephone. Firm- initiated recall ongoing. DISTRIBUTION California, Idaho, Utah. QUANTITY 185 cases (6 bottles per case) were distributed. REASON Product is fermenting.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

________ PRODUCT Platelets. Recall #B-1225-0. CODE Unit Numbers: 3185171, 3185170, 3185417, 3183986, 3348267, 3348269, 3348271, 3183998, 3801648, 3185250, 3185439, 3185440, 3185257, 3185435, 3801649, 3185444, 3800870, 3800865, 3348287, 3800875, 3185437, 3800869, 3185436. MANUFACTURER Florida Blood Services, St. Petersburg, Florida. RECALLED BY Manufacturer, by telephone on January 14, 1998, followed by letter. Firm-initiated recall complete. DISTRIBUTION Florida. QUANTITY 23 units were distributed. REASON Blood products were manufactured using a centrifuge that failed quality control testing. ________ PRODUCT a) Red Blood Cells; b) Platelets. Recall #B-001/002-1. CODE Unit Numbers: a) 81-33372, 81-31830, 81-30379, 81-28766; b) 81-33372, 81-31830. MANUFACTURR Northwest Michigan Blood Program, Traverse City, Michigan. RECALLED BY Michigan Community Blood Centers, Grand Rapids, Michigan, by letter on December 24, 1999. Firm-initiated recall complete. DISTRIBUTION Florida and Michigan. QUNTITY a) 4 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 a) Red Blood Cells; b) Platelets. Recall #B-003/004-1. CODE Unit Numbers: a) 81-28968, 81-33545; b) 81-28968. MANUFACTURER Northwest Michigan Blood Program, Traverse City, Michigan. RECALLED BY Michigan Community Blood Centers, Grand Rapids, Michigan, by letter on November 29, 1999. Firm-initiated recall complete. DISTRIBUTION Michigan. QUANTITY a) 2 units; b) 1 unit distributed. REASON Blood products were collected from a donor who reported travel to an area designated as endemic for malaria. ________ PRODUCT a) Red Blood Cells; b) Platelets. Recall #B-005/006-1. CODE Unit #65-17673. MANUFACTURER Michigan Community Blood Centers, Grand Rapids, Michigan. RECALLED BY Manufacturer, by letter on October 28, 1999. Firm-initiated recall complete. DISTRIBUTION Michigan. 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 s) Red Blood Cells; b) Platelets. Recall #B-007/008-1. CODE Unit Numbers: a) 18347-9597; b) 16347-9565, 16347-9566, 16347-9572, 16347-9598, 16347-9600, 16349-0789, 16349-1185, 16349-1188, 18347-9597. MANUFACTURER Blood Systems, Inc., Hattiesburg, Mississippi. RECALLED BY Manufacturer, by telephone on June 1, 1999. Firm-initiated recall complete. DISTRIBUTION Mississippi. QUANTITY a) 1 unit; b) 9 units were distributed. REASON Blood products were prepared from overweight whole blood units. ________ PRODUCT a) Red Blood Cells, Leukocytes Reduced; b) Platelets. Recall #B-009/010- 1. CODE Unit #18FE65459. MANUFACTURER American Red Cross, Lansing, Michigan. RECALLED BY Manufacturer, by letter on February 7, 1999. Firm-initiated recall complete. DISTRIBUTION Michigan. 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 a) Red Blood Cells; b) Recovered Plasma. Recall #B-012/013-1. CODE Unit #38FK02777. MANUFACTURER American Red Cross Blood Services, Fort Wayne, Indiana. RECALLED BY Manufacturer, by telephone and letter on September 7, 1999. Firm- initiated recall complete. DISTRIBUTION Indiana and New York. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor who had taken the medication Methotrexate. ________ PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma. Recall #B-014/016-1. CODE Unit Numbers: a) 32KF46845 and 32KF32535; b) 32KF32535; c) 32KF46845. MANUFACTURER American Red Cross Blood Services, Madison, Wisconsin. RECALLED BY Manufacturer, by letter dated August 31, 1999. Firm-initiated recall complete. DISTRIBUTION Iowa and Wisconsin. QUANTITY a) 2 units; b) 1 unit; c) 1 unit distributed. REASON Blood products were collected from a donor who reported previously testing positive for hepatitis. ________ PRODUCT a) Platelets; b) Cryoprecipitated AHF; c) Recovered Plasma. Recall #B-017/019-1. CODE Unit Numbers: a) 32KG96828; b) 32KM11803; c) 32KM11803 and 32KG96828. MANUFACTURER American Red Cross Blood Services, Madison, Wisconsin. RECALLED BY Manufacturer, by letter dated April, 8, 1999, followed by telephone on April 6 and 12, 1999. Firm-initiated recall complete. DISTRIBUTION Illinois, Wisconsin, New York, Switzerland. QUANTITY a) 1 unit; b) 1 unit; c) 2 units were distributed. REASON Blood products were collected from a donor who reported previously testing positive for anti-HCV. ________ PRODUCT a) Red Blood Cells; b) Fresh Frozen Plasma. Recall #B-020/021-1. CODE Unit #32KC00739. MANUFACTURER American Red Cross Blood Services, Madison, Wisconsin. RECALLED BY Manufacturer, by letters dated August 11 and 16, 1999. Firm-initiated recall complete. DISTRIBUTION Iowa and Wisconsin. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor who reported previously testing positive for hepatitis. ________ PRODUCT Red Blood Cells. Recall #B-022-1. CODE Unit #32LG00698. MANUFACTURER American Red Cross Blood Services, Chicago, Illinois. RECALLED BY American Red Cross Blood Services, Madison, Wisconsin, by telephone on December 22, 1998. Firm-initiated recall complete. DISTRIBUTION Illinois. QUANTITY 1 unit was distributed. REASON Blood product was collected in a manner that could compromise the sterility of the product. ________ PRODUCT Platelets. Recall #B-023-1. CODE Unit #32KG90713. MANUFACTURER American Red Cross Blood Services, Madison, Wisconsin. RECALLED BY Manufacturer, by telephone on May 22, 1998. Firm-initiated recall complete. DISTRIBUTIONB Wisconsin. QUANTITY 1 unit was distributed. REASON Blood product tested repeatedly reactive for anti-HBc. ________ PRODUCT a) Red Blood Cells; b) Red Blood Cells, Leukoreduced. Recall #B-025/026-1. CODE Unit Numbers: a) 17KC08284; b) 17KF91138 and 17KL77510. MANUFACTURER American Red Cross Blood Services, St. Paul, Minnesota. RECALLED BY Manufacturer, by telephone on September 10, 1999. Firm-initiated recall complete. DISTRIBUTION Minnesota and Wisconsin. QUANTITY a) 1 unit; b) 2 units were distributed. REASON Blood product corresponded to a unit of pooled platelets that was positive for Serratia marcescens and implicated in a transfusion reaction. ________ PRODUCT a) Red Blood Cells; b) Platelets. Recall #B-027/028-1. CODE Unit #9437822. MANUFACTURER Medic Regional Blood Center, Knoxville, Tennessee. RECALLED BY Manufacturer, by letters dated August 15, 1997, and September 2, 1997. Firm-initiated recall complete. DISTRIBUTION Tennessee. QUANTITY 1 unit of each component was distributed. REASON 1 unit of each component was distributed. REASON Blood products tested negative for anti-HBc, but were collected from a donor who previously tested repeatedly reactive for anti-HBc on two separate occasions, and also tested repeatedly reactive for anti-HBc on a subsequent donation. ________ PRODUCT Platelets, Pheresis, Leukoreduced. Recall #B-029-1. CODE Unit #32LP00737. MANUFACTURER American Red Cross Blood Services, Chicago, Illinois. RECALLED BY American Red Cross Blood Services, Madison, Wisconsin, by letter dated April 28, 2000. Firm-initiated recall complete. DISTRIBUTION Illinois. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who traveled to an area considered endemic form malaria. ________ PRODUCT Red Blood Cells. Recall #B-030-1. CODE Unit #32KF62196. MANUFACTURER American Red Cross Blood Services, Madison, Wisconsin. RECALLED BY Manufacturer, by letter dated October 21, 1999. Firm-initiated recall complete. DISTRIBUTION Illinois. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who traveled to an area considered endemic for malaria. ________ PRODUCT a) Red Blood Cells; b) Recovered Plasma. Recall #B-031/032-1. CODE Unit #32KQ31773. MANUFACTURER American Red Cross Blood Services, Madison, Wisconsin. RECALLED BY Manufacturer, by letter dated December 15, 1999, or by telephone on December 3, 1999. Firm-initiated recall complete. DISTRIBUTION Illinois and New York. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor who had close contact with a hemophiliac who tested positive for HBsAg and HIV were distributed prior to receipt of this information. ________ PRODUCT a) Red Blood Cells; b) Recovered Plasma. Recall #B-034/035-1. CODE Unit #32KL01022. MANUFACTURER American Red Cross Blood Services, Madison, Wisconsin. RECALLED BY Manufacturer, by letter dated May 14, 1999, or by telephone on May 11, 1999. Firm-initiated recall complete. DISTRIBUTION Iowa and California. QUANTITY 1 unit was distributed. REASON Blood products were collected from a donor who reported previously testing positive for hepatitis. ________ PRODUCT a) Red Blood Cells; b) Platelets; c) Recovered Plasma. Recall #B-050/052-1. CODE Unit #17KF65369. MANUFACTURER American Red Cross, North Central Blood Services, St. Paul, Minnesota. RECALLED BY Manufacturer, by letter dated April 13, 2000. Firm-initiated recall complete. DISTRIBUTION Pennsylvania, Minnesota, California. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from an unsuitable donor. ________ PRODUCT Red Blood Cells. Recall #B-053-1. CODE Unit #12436-1245. MANUFACTURER United Blood Services, Albuquerque, New Mexico. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by telephone on February 26, 1999. Firm-initiated recall complete. DISTRIBUTION New Mexico. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor whose hemoglobin had not been documented. ________ PRODUCT Source Plasma. Recall #B-056-1. CODE Unit Numbers: 91454874, 91456656, 89940495, 89942307, 89945858, 94318180, 94242089, 94243864 MANUFACTURER Sera-Tec Biologicals, Ltd., Norfolk, Virginia. RECALLED BY Manufacturer, by letter dated June 30, 1998. Firm-initiated recall complete. DISTRIBUTION California. QUANTITY 8 units were distributed. REASON Blood products were collected from a donor who had been deferred due to a history of incarceration. ________ PRODUCT Red Blood Cells. Recall #B-059-1. CODE Unit Numbers: 17KW09327 and 17KW09332. MANUFACTURER American Red Cross, St. Paul, Minnesota. RECALLED BY Manufacturer, by letters dated April 25, 2000, and May 4, 2000. Firm- initiated recall complete. DISTRIBUTION Pennsylvania and Iowa. QUANTITY 2 units were distributed. REASON Blood products were collected from two donors who reported travel to an area designated as endemic for malaria. ________ PRODUCT Red Blood Cells. Recall #B-065-1. CODE Unit #2277494. MANUFACTURER Florida Georgia Blood Alliance, Inc., Jacksonville, Florida. RECALLED BY Manufacturer, by letter dated April 28, 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 a) Red Blood Cells; b) Platelets. Recall #B-066/067-1. CODE Unit Numbers: a) 53FR54570, 54FQ51284, 53L87653; b) 53FR54570, 53L87653. MANUFACTURER American Red Cross Blood Services, Baltimore, Maryland. RECALLED BY Manufacturer, by letter dated March 3, 1997. Firm-initiated recall complete. DISTRIBUTION Virginia, Maryland, District of Columbia. 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 a) Red Blood Cells; b) Recovered Plasma. Recall #B-069/070-1. CODE Unit #4783555. MANUFACTURER Department of the Navy, National Naval Medical Center, Blood Bank, Bethesda, Maryland. RECALLED BY Manufacturer, by telephone on April 16, 1999, and by letter on May 3, 1999. Firm-initiated recall complete. DISTRIBUTION Maryland and California. QUANTITY 1 unit of each component was distributed. REASON Blood products tested negative for anti-HCV, but were collected from a donor who previously tested reactive for anti-HCV. ________ PRODUCT Red Blood Cells, Leukoreduced, Irradiated. Recall #B-073-1. CODE Unit #41FQ66760. MANUFACTURER The American National Red Cross, North Birmingham, Alabama. RECALLED BY Manufacturer, by telephone on July 26, 1999. Firm-initiated recall complete. DISTRIBUTION Alabama. QUANTITY 1 unit was distributed. REASON Blood product tested positive for Cytomegalovirus (CMV) but was labeled negative for CMV. ________ PRODUCT a) Red Blood Cells; b) Recovered Plasma. Recall #B-085/086-1. CODE Unit #38H54178. MANUFACTURER American Red Cross Blood Services, Fort Wayne, Indiana. RECALLED BY Manufacturer, by letter dated June 1, 1999, and by fax on May 26, 1999. Firm-initiated recall complete. DISTRIBUTION Indiana and New York. QUANTITY 1 unit of each component was distributed. REASON Blood product was collected from a donor who lived in an HIV Group O risk area.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

________ PRODUCT Red Blood Cells, Autologous. Recall #B-033-1. CODE Lot #32KF63177. MANUFACTURER American Red Cross Blood Services, Madison, Wisconsin. RECALLED BY Manufacturer, by telephone on July 20, 1999, and by letter on September 16, 1999. Firm-initiated recall complete. DISTRIBUTION Wisconsin. QUANTITY 1 unit was distributed. REASON Blood product which tested repeatedly for anti-HBc, was distributed without a biohazard label. ________ PRODUCT Red Blood Cells. Recall #B-038-1. CODE Unit #87-12399. MANUFACTURER Michigan Community Blood Centers, Grand Valley Blood Program, Grand Rapids, Michigan. RECALLED BY Manufacturer, by letter dated June 11, 1999. Firm-initiated recall complete. DISTRIBUTION Michigan. QUANTITY 1 unit was distributed. REASON Blood product was not separated from the unit of whole blood and refrigerated within eight hours of collection. ________ PRODUCT Rabies Vaccine, Imovax Rabies I.D. Recall #B-047-1. CODE Lot Numbers: N1204-2, P0030-2, and P0313-3. MANUFACTURER Aventis Pastuer SA, Marcy L' Etoile, Lyon, France. RECALLED BY Aventis Pasteur, Inc., Swiftwater, Pennsylvania, by telephone and letter dated July 27, 2000. Firm-initiated recall complete. DISTRIBUTION Nationwide. QUANTITY 5,656 syringes of lot P0313, 5,375 syringes of lot P0030, and 5,932 syringes of lot N1204. REASON Rabies vaccine failed to demonstrate adequate potency throughout the dating period. ________ PRODUCT Red Blood Cells. Recall #B-049-1. CODE Unit #17KJ94652. MANUFACTURER American Red Cross Blood Services, St. Paul Minnesota. RECALLED BY Manufacturer, by letters on March 6, 2000, and April 13, 2000. Firm- initiated recall complete. DISTRIBUTION Michigan. QUANTITY 1 unit was distributed. REASON Fresh Frozen Plasma, implicated in a transfusion reaction, was found to be contaminated with Propionbacterium acnes. The corresponding Red Blood Cells had been distributed. ________ PRODUCT Red Blood Cells Leukoreduced. Recall #B-054-1. CODE Unit #C42758. MANUFACTURER Virginia Blood Services, Richmond, Virginia. RECALLED BY Manufacturer by letter dated June 5, 2000. Firm-initiated recall complete. DISTRIBUTION Virginia. QUANTITY 1 unit was distributed. REASON Blood product tested reactive for syphilis. ________ PRODUCT Red Blood Cells, Irradiated. Recall #B-055-1. CODE Unit numbers: 7715854 and 7715861. MANUFACTURER Department of the Navy, National Navy Medical Center, Blood Bank, Bethesda, Maryland. RECALLED BY Manufacturer, by telephone on April 9 and 20, 1998. Firm-initiated recall complete. DISTRIBUTION District of Columbia QUANTITY 2 units were distributed. REASON Unlicensed blood products were distributed in interstate commerce. ________ PRODUCT Red Blood Cells, Leukocytes Reduced, Irradiated. Recall #B-057-1. CODE Unit numbers: 17FZ19683, 17FZ19684, and 17FZ19695. MANUFACTURER American Red Cross, North Central Blood Services, St. Paul, Minnesota. RECALLED BY Manufacturer, by letter dated September 13, 1999. Firm-initiated recall complete. DISTRIBUTION Minnesota. QUANTITY 3 units were distributed. REASON Blood products were stored at unacceptable temperatures. ________ PRODUCT Platelets Pheresis. Recall #B-060-1. CODE Unit #12W41015. MANUFACTURER American Red Cross Blood Services, Charlotte, North Carolina. RECALLED BY Manufacturer, by telephone on February 15, 2000. Firm-initiated recall complete. DISTRIBUTION North Carolina. QUANTITY 1 unit was distributed. REASON Blood product was stored at an unacceptable temperature. ________ PRODUCT Platelet Pheresis. Recall #B-064-1. CODE Unit numbers: 03P19916 and 03P19919. MANUFACTURER American Red Cross Blood Services, Atlanta, Georgia. RECALLED BY Manufacturer, by letter dated June 2, 1999. Firm-initiated recall complete. DISTRIBUTION Georgia. QUANTITY 2 units were distributed. REASON Blood products were stored under inappropriate conditions. ________ PRODUCT Whole Blood. Recall #B-068-1. CODE Unit #3601045. MANUFACTURER Florida Georgia Blood Alliance, Inc., Jacksonville, Florida. RECALLED BY Manufacturer, by telephone on June 11, 2000. Firm-initiated recall complete. DISTRIBUTION Florida. QUANTITY 1 unit was distributed. REASON Blood product was labeled with an extended expiration date. ________ PRODUCT Fresh Frozen Plasma. Recall #B-071-1. CODE 36LQ21799, 36LQ21813, 36LQ21818, 36LQ21839, 36LQ21826, and 36LQ21842. MANUFACTURER American Red Cross Blood Services, Columbia, South Carolina. RECALLED BY Manufacturer, by letter dated March 29, 1999. Firm-initiated recall complete. DISTRIBUTION South Carolina. QUANTITY 6 units were distributed. REASON Blood products were labeled with an extended expiration date. ________ PRODUCT Red Blood Cells Irradiated. Recall #B-072-1. CODE Unit #2287731. MANUFACTURER Central Texas Regional Blood and Tissue Center, Austin, Texas. RECALLED BY Manufacturer, by telephone on March 6, 2000. Firm-initiated recall complete. DISTRIBUTION Texas. QUANTITY 1 unit was distributed. REASON Blood product was labeled with an extended expiration date. ________ PRODUCT Platelets Pheresis, Leukoreduced. Recall #B-074-1. CODE Unit #41GP29618. MANUFACTURER The American National Red Cross, Birmingham, Alabama. RECALLED BY Manufacturer, by letter dated November 26, 1999. Firm-initiated recall complete. DISTRIBUTION Alabama. QUANTITY 1 unit was distributed. REASON Unlicensed blood product was labeled with the firmís license number. ________ PRODUCT Fresh Frozen Plasma, Pheresis, Donor Retested. Recall #B-075-1. CODE Unit numbers: 4800553, 4800570, 4800559, 4800704, 4800561, 4800705, and 4800698. MANUFACTURER West Tennessee Regional Blood Center, Inc., Jackson, Tennessee. RECALLED BY Manufacturer, by letter dated October 20, 1998. Firm-initiated recall complete. DISTRIBUTION Tennessee. QUANTITY 7 units were distributed. REASON Unlicensed blood products were labeled with the firmís license number. ________ PRODUCT Source Plasma. Recall #B-076-1. CODE Unit #VL056119. MANUFACTURER Sera-Tec Biologicals Limited Partnership, Shreveport, Louisiana. RECALLED BY Manufacturer, by letter dated January 5, 2000. Firm-initiated recall complete. DISTRIBUTION North Carolina. QUANTITY 1 unit was distributed. REASON Blood product was untested for viral markers. END OF ENFORCEMENT REPORT FOR OCTOBER 18, 2000.
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