March 15, 2000 00-11
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
________ PRODUCT Sysco 10" TNS Pumpkin Pie 1488469, Sysco 10" TNS Sweet Potato Pie 2011955, and Sysco 10" TNS Southern Pecan Pie 1020718. Recall #F-177/179-0. CODE All code dates. MANUFACTURER Flowers Baking Company of South Carolina, Inc., Spartanburg, South Carolina; Daniel's Home Bakery of North Carolina, Pembroke, North Carolina. RECALLED BY Mrs. Smith's Bakeries, Inc., Suwanee, Georgia, by letter on December 2 and 3, 1999. Firm-initiated field correction (relabeling) complete. DISTRIBUTION Nationwide. QUANTITY Approximately 42,928 cases of Southern Pecan; 9,849 cases of Sweet Potato, and 40,560 cases of Pumpkin were distributed. REASON Products contain undeclared dairy and egg ingredients.RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
________ PRODUCT Various chocolate candies in non-seasonal trays of varying weights as described below: Dark Chocolate: 1. Vanilla Butter Creams 8.5 oz 2. Peanut Butter Cups 8.5 oz 3. Orange Peel 6 oz 4. Cordial Cherries 8.5 oz 5. Mint Melt Aways 7 oz 6. Thin Mints 7 oz 7. Almond Bark 6.5 oz 8. Pecan Bark 6.5 oz 9. Mousse Truffles 7.5 oz 10. Cracker 6 oz 11. Caramel Pretzel Patty 8.5 oz Milk Chocolate: 12. Vanilla Butter Creams 8.5 oz 13. Peanut Butter Cups 8.5 oz 14. Orange Peel 6 oz 15. Cordial Cherries 8.5 oz 16. Mint Melt Aways 7 oz 17. Thin Mints 7 oz 18. Almond Bark 6.5 oz 19. Pecan Bark 6.5 oz, 20. Mousse Truffles 7.5 oz 21. Pecan Patties 8.5 oz Various chocolate candies in non-seasonal cardboard tubs of varying weights as described below: 22. Almond Butter Crunch 8 oz 23. White Chocolate Chips 8 oz 24. Pure Butter Scotch 12 oz 25. Peanut Crunch 7 oz. 26. Mint Chips 8.5 oz. 27. Black Walnut Hash 10 oz. 28. Milk chocolate Almond 7.5 oz. 29. Peanut Butter Truffles 8.5 oz. 30. Milk Chocolate Pretzel chips 7.5 oz. 31. Molasses Butter Taffy 13 oz. 32. Pecan Crunch 6 oz. 33. Peanut Brittle 9 oz. 34. Dark Chocolate Wafers 10 oz. 35. Milk Chocolate Wafers 10 oz. Recall #F-124/158-0. CODE None. MANUFACTURER Josh Early Candies, Inc., Allentown, Pennsylvania. RECALLED BY Manufacturer, by placing placards in store on or about December 14, 1999. Firm-initiated field correction (relabeling) complete. DISTRIBUTION Pennsylvania. QUANTITY Dark Chocolate: 22 Vanilla Butter Creams 8.5 oz, 24 Peanut Butter Cups 8.5 oz, 14 Orange Peel 6 oz 15 Cordial Cherries 8.5 oz, 14 Mint Melt Aways 7 oz, 24 Thin Mints 7 oz, 1 Almond Bark 6.5 oz, 44 Pecan Bark 6.5 oz, 14 Mousse Truffles 7.5 oz, 9 Cracker 6 oz, 14 Caramel Pretzel Patty 8.5 oz Milk Chocolate: 12 Vanilla Butter Creams 8.5oz 13 Peanut Butter Cups 8.5 oz 37 Orange Peel 6 oz 33 Cordial Cherries 8.5 oz 9 Mint Melt Aways 7 oz 22 Thin Mints 7 oz 34 Almond Bark 6.5 oz 6 Pecan Bark 6.5 oz 9 Mousse Truffles 7.5 oz 16 Pecan Patties 8.5 oz Current inventory of non-seasonal cardboard tub candies still held for sale on 12/21/99. 24 Almond Butter Crunch 8 oz 10 White Chocolate Chips 8 oz, 10 Pure Butter Scotch 12 oz 9 Peanut Crunch 7 oz, 10 Mint Chips 8.5 oz 19 Black Walnut Hash 10 oz, 15 Milk Choco. Almond 7.5 oz 13 Peanut Butter Truffles 8.5 oz 10 Mk Choco.Pretzel Chips7.5oz 12 Molasses Butter Taffy 13 oz 12 Pecan Crunch 6 oz 8 Peanut Brittle 9 oz 16 Dk Choco. Wafers 10 oz 25 Milk Chocolate Wafers 10 oz. REASON Products do not bear ingredient statements and contain ingredients (peanuts, pecans, walnuts, almonds, dairy products, FD&C Yellow No.5 and FD&C Yellow No.6) which can elicit reactions in sensitive individuals. ________ PRODUCT a) Rica Sunland brand Sweet Crackers; b) Cien en Boca brand Cookies. Recall #F-180/181-0. CODE Lots manufactured from September 1999 to January 2000. RICA Label: 9250 9256 9277 9284 9298 9312 9322 9340 9347 9361 CIEN EN BOCA Label: 9277 9284 9285 9300 9301 9302 9309 9313 9314 9320 9322 9326 9327 9330 9337 9344 9351 9352 9355 9356 9357 9358 9361 9362 9363 9315 9316. MANUFACTURER Borinquen Biscuit Corporation, Yauco, Puerto Rico. RECALLED BY Manufacturer, by visiting/notifying the customers on February 1, 2000. Firm-initiated field correction (relabeling) ongoing. DISTRIBUTION New Jersey, Florida, Pennsylvania, Illinois, New York, Connecticut, Puerto Rico, Virgin Islands. QUANTITY Firm distributed the following: Rica Brand: 14,992 48-ounce cans; 16,398 24-ounce cans; 86,738 20-ounce cans; 124,272 8-ounce boxes; Cien en Boca Brand: 31,920 14-ounce cans; 1,722 25-pound bags. REASON Products contain undeclared FD&C Yellow No. 5 and FD&C Yellow No. 6.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
________ PRODUCT OTC items packaged in plastic jars and distributed under the Gabriel SkinCare label: Aloe Care (Hydrocortisone cream), 32 ounce jar Blemish Control Mask (sulfur), 64 ounce jar SPF 16 Sunblock Gel, 4 ounce jar SPF 25 Sunblock Gel, 4 ounce jar SPF 30 Sunblock Lotion, 32 ounce jar SPF 30 Waterproof Sunblock Lotion, 32 ounce jars. Recall #D-228/233-0. CODE All lot numbers. MANUFACTURER Gabriel Skin care Distributors, Inc., Westlake, Ohio (Distributor/responsible firm). RECALLED BY Distributor, by letter mailed on February 4, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. and Puerto Rico. QUANTITY A total of 505 jars of product (SPF 16-2 units, SPF 25-212 units, SPF 30-57 units, SPF 30 Waterproof-86 units, Aloe Cort-47 units, Blemish Control-101 units) have been distributed since 1/25/1997. REASON Failure to perform active ingredient testing ________ PRODUCT Oxygen, USP, Compressed in 165 (M-6) and 650 (E) liter aluminum cylinders. Recall #D-241-0. CODE Lot Numbers 11199901, 12029902, 12089903, 12169904, 12239905, 12319906, 01070087, 01140008, and 01210009. MANUFACTURER Satilla Home Care, Waycross, Georgia. RECALLED BY Manufacturer, by visit beginning on or about January 31, 2000. Firm-initiated recall complete. DISTRIBUTION Georgia. QUANTITY 98/E cylinders (650 liters) and 125/M-6 cylinders (165 liters) were filled under the recalled lots. The firm estimates that about 50% of those cylinders remained in the homes of patients at time of recall initiation. REASON Current good manufacturing practice deviations - Use of an invalidated oxygen analyzer for assays. ________ PRODUCT Oxygen USP, compressed, in various sizes of steel and aluminum cylinders. Recall #D-242-0. CODE All lots. MANUFACTURER Southern Welding Supply, Inc., Savannah, Georgia. RECALLED BY Manufacturer, by visit November 5, 1999. Firm-initiated recall complete. DISTRIBUTION Georgia and South Carolina. QUANTITY Undetermined. REASON Current good manufacturing deviations including but not limited to failure to test each batch of oxygen for identity and purity prior to release. ________ PRODUCT Lithobid (r) Slow Release Tablets (Lithium Carbonate, USP), in 300 mg bottles of 100, Rx. Recall #D-243-0. CODE Lot #90573. MANUFACTURER Solvay Pharmaceuticals, Inc., Marietta, Georgia. RECALLED BY Manufacturer, by letter dated January 18, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 14,317 bottles were distributed. REASON Dissolution failure at stability testing. ________ PRODUCT Solu-CortefÆ Sterile Powder for injection, (Hydrocortisone Sodium Succinate), 100 mg, 25-2 mL ACT-O-VL, Rx. NDC #0009-0900-20. Recall #D-244-0. CODE Lot Numbers: 12654 and 13044 EXP 03/04. MANUFACTURER Pharmacia & Upjohn Company, Kalamazoo, Michigan. RECALLED BY AmeriSource Health Services Corporation, doing business as American Health Packaging (AHP) (repacker/relabeler/distributor), Columbus, Ohio, by letter mailed on February 8, 2000. Firm-initiated recall ongoing. DISTRIBUTION Ohio, New Jersey, Massachusetts, Tennessee, California. QUANTITY 128 bags were distributed. REASON Lack of assurance of sterility.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
________ PRODUCT NeutrexinÆ Injection (Trimetrexate glucuronate for injection), 25mg, in single vial, 10 pack vials and 50 pack vials, Rx for indicated for use with concurrent leucovorin administration, as an alternative therapy for the treatment of moderate to severe Pneumocystis carinii pneumonia (PCP) in immunocompromised patients, including patients with AIDS, who are intolerant of, or are refractory to, trimethoprim-sulfamethoxazole therapy. Single vial NDC #58178-020-01, 1-pack NDC #58178-020-10, and 50-pack NDC #58178-020-50. Recall #D-234-0. C0DE Lot #1020G EXP 12/00. MANUFACTURER Ben Venue Laboratories, Bedford, Ohio. RECALLED BY U.S. BioScience, Inc., West Conshohocken, Pennsylvania, by letter dated February 8, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 20,727 vials were distributed; firm estimated that less than 1,000 vials remained on market at time of recall initiation. REASON Lyophilized cake discoloration (white to tan). ________ PRODUCT OTC items packed in 32 and 64-ounce plastic jars used for the treatment of facial acne, distributed under the Grabriel SkinCare label: a) Blemish Control Gel 2.5%, in 32 ounce jars b) Blemish Control Gel 5%, in 32-ounce jars c) Blemish Control Gel 10%, in 32-ounce jars d) Blemish Wash, in 64-ounce jars e) Blemish Scrub, in 64-ounce jars. Recall #D-235/239-0. CODE Lot Numbers: a) 3612; b) 3435; c) 3582; d) 3312 and 3470; e) 3200 and 3569. MANUFACTURER Gabriel Skin Care Distributors, Inc., Westlake, Ohio (Distributor/Responsible Firm). RECALLED BY Distributor, by letter on February 11, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and Puerto Rico. QUANTITY 118 jars were distributed. REASON a) Misbranding. b-e) Failure to perform active ingredient testing. ________ PRODUCT Ibuprofen Caplets/Tablets, 200 mg, 100 and 500 unit bottles, OTC, packaged under the Discount Drug Mart, Bindley Western and Fred's label. Recall #D-240-0. CODE Lot Numbers: 9071040, 0019547, 9056970, and 9046736. MANUFACTURER Granutec, Wilson, North Carolina. RECALLED BY Manufacturer, by telephone on February 2 and 3, 2000, and by letters faxed or mailed on February 3, 2000. Firm-initiated recall ongoing. DISTRIBUTION Ohio, Tennessee, Connecticut. QUANTITY The firm estimates 2,300 bottles of 500-count are in the marketplace for lot numbers 9071040 and 0019547 that were shipped to Discount Drug. The firm estimates that no material remains in the marketplace for the lots shipped to Fred's Inc. and Bindley Western. REASON Misbranding - The carton and insert do not list the correct inactive ingredients. ________ PRODUCT Urinary Antiseptic Film Coated Tablets, (Methenamine 40.8 mg), in 100 and 1,000 tablets bottles, under the following labels: Contract Pharmacal Corporation- NDC #10267-1724-1 & 10267-1724-4; Major Pharmaceuticals - NDC #0904-5369-60; Breckenridge Pharmaceutical - NDC #51991-027-01. Recall #D-245-0. CODE Lot Numbers: 081230 EXP 2/00, 081323 EXP 3/00, 081493 EXP 4/00, 083889 EXP 10/00, 084325 EXP 1/01, 084326 EXP 1/01, 084685 EXP 4/01, 091564 EXP 5/01, 091648 EXP 6/01 091896 EXP 7/01 and 092891 EXP 8/01. MANUFACTURER Contract Pharmacal Corporation (CPC), Hauppauge, New York. RECALLED BY Manufacturer, by letter on January 11, 2000, followed by visit on January 20-21, 2000. Firm-initiated recall ongoing. DISTRIBUTION Michigan, New York, Florida, Georgia, Pennsylvania, California, Kentucky, Ohio, Tennessee, Connecticut, West Virginia, Louisiana, Indiana, New Jersey, Puerto Rico. QUANTITY 69,376 units (100-count bottles), 1,776 units (1000-count bottles) and 1,864.9 million bulk tablets were distributed. REASON Tablet discoloration. ________ PRODUCT Testosterone USP, Micronized, non-sterile powder, in 5 gram bottles, Rx. Recall #D-246-0. CODE Lot #9M6014 EXP 2/04. MANUFACTURER Paddock Laboratories, Inc., Minneapolis, Minnesota (repacker/responsible firm). RECALLED BY Manufacturer, by letter dated February 21, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 1,062 bottles were distributed. REASON Mislabeling - Some units may contain Testosterone Propionate USP Powder. ________ PRODUCT Clobetasol Propionate Topical Solution, USP, 0.05%, in 25 mL bottles, Rx for the treatment of inflammatory and pruritic manifestations of moderate to severe corticosteroid responsive dermatoses of the scalp. NDC #0168-0269-25. Recall #D-247-0. CODE Lot #D095 EXP 2/01. MANUFACTURER E. Fougera and Company, A Division of Altana, Inc., Melville, New Jersey. RECALLED BY Manufacturer, by letter on November 18, 1999. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 876 bottles were distributed; firm estimated that 20 percent of product remained on market at time of recall initiation. REASON Product exceeds a degradant level at 6-month stability testing. ________ PRODUCT Hydrocortisone (1%) and Acetic Acid (2%) Otic Solution, USP, in 10 mL bottles, Rx non-aqueous solution product used as an antibacterial and anti-fungal agent in the external ear canal, under the Thames label NDC #49158-197-43, and Qualitest label NDC #0603-7036-39. Recall #D-248-0. CODE Lot Numbers: M494 EXP 12/99 M501, EXP 12/99 M530, EXP 2/00 M568, EXP 9/00 M581, EXP 9/00 M644, EXP 11/00 M775, EXP 3/01. MANUFACTURER Thames Pharmacal Company, Inc., Ronkonkoma, New York. RECALLED BY Manufacturer, by fax letter dated September 24, 1999. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 91,599 bottles were distributed; firm estimated that 25 percent of product remained on market at time of recall initiation. REASON Subpotency (18 month sability). ________ PRODUCT Acetic Acid Otic Solution, USP, 2%, in 15 mL units, Rx non-aqueous solution used as an antibacterial and anti-fungal agent in the external ear canal, under the following labels: Major NDC 0904-0315-35, Schein NDC 0364-0732-72; Qualitest NDC 0603-7035-41. Recall #D-249-0. CODES Lot Numbers: M235 EXP 4/00, M529, EXP 7/00, M558 EXP 8/00 M583 EXP 9/00, M655 EXP 1/01, M854 EXP 5/01. MANUFACTURER Thames Pharmacal Company, Inc., Ronkonkoma, New York. RECALLED BY Manufacturer, by letter faxed on November 9, 1999, and by mail on November 11-12, 1999. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 73,737 bottles were distributed; firm estimated that 25 percent of product remained on market at time of recall initiation. REASON Subpotency (15 month stability).RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
________ PRODUCT a) Red Blood Cells; b) Recovered Plasma. Recall #B-428/429-0. CODE Unit #35FH28525. MANUFACTURER American Red Cross, Roanoke, Virginia. RECALLED BY Manufacturer, by letters dated September 14, 1999, and October 22, 1999, and by fax on September 3, 1999. Firm-initiated recall complete. DISTRIBUTION Puerto Rico and New York. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor with a history of Hepatitis. ________ PRODUCT Platelets, Pheresis. Recall #B-440-0. CODE Unit #P19202. MANUFACTURER The Blood Center of Central Iowa, Des Moines, Iowa. RECALLED BY Manufacturer, by telephone on July 19, 1999, and by letter dated July 26, 1999. Firm-initiated recall complete. DISTRIBUTION Iowa. QUANTITY 1 unit was distributed. REASON Blood product had an unacceptable platelet count. ________ PRODUCT a) Red Blood Cells; b) Platelets; c) Recovered Plasma. Recall #B-473/475-0. CODE Unit #42FY93813. MANUFACTURER American Red Cross Blood Services, Cleveland, Ohio. RECALLED BY Manufacturer, by letter dated September 30, 1999. Firm-initiated recall complete. DISTRIBUTION Ohio 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 Corneas. Recall #B-476-0. CODE Identification Numbers: 0045-00-01 and 0045-00-02. MANUFACTURER Lions Medical Eye Bank and Research Center of Eastern Virginia, Norfolk, Virginia. RECALLED BY Manufacturer, by letter dated January 21, 2000. Firm-initiated recall ongoing. DISTRIBUTION West Virginia. QUANTITY 2 units were distributed. REASON Corneas were collected from a door who tested repeatedly reactive for the Hepatitis B core antibody (anti-HBc). ________ PRODUCT Various Human Freeze Dried Bone and/or Frozen Musculoskeletal Tissues for Transplant including: Corticocancellous Chips, Cancellous Cubes, Cloward Dowel, Frozen Archilles Tendon, Frozen Bisected Patellar, Frozen Distal Femur, Frozen Femoral Head, Frozen Fibula Condyle, Frozen Humeral Head, Fibula Segment, Fascia Lata, Frozen Whole Patellar, Iliac Crest Wedge. Recall #B-477-0. CODE Donor ID: KHV019, LAC732, LAY499, LAH897. MANUFACTURER LifeNet, Virginia Beach, Virginia (processor). RECALLED BY New England Organ Bank, Newton, Massachusetts, by letter on January 24, 2000. Firm-initiated recall ongoing. DISTRIBUTION Massachusetts, Connecticut, Vermont, Maine, New Hampshire, Rhode Island, Kentucky, Louisiana, Virginia. QUANTITY 133 grafts distributed. REASON Various tissues for transplant which were collected from four donors who had not been properly evaluated. ________ PRODUCT Red Blood Cells. Recall #B-478-0. CODE Unit #3544246. MANUFACTURER Gulf Coast Regional Blood Center, Houston, Texas. RECALLED BY Manufacturer, by telephone and fax on March 15, 1999. Firm-initiated recall complete. DISTRIBUTION Texas. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who received a tattoo within 12 months of donation. ________ PRODUCT Red Blood Cells. Recall #B-479-0. CODE Unit #4456418. MANUFACTURER Inland Northwest Blood Center, Spokane, Washington. RECALLED BY Manufacturer, by telephone on September 28, 1999. Firm-initiated recall complete. DISTRIBUTION Washington state. QUANTITY 1 unit was distributed. REASON Blood product was incorrectly tested for CMV. ________ PRODUCT Platelets. Recall #B-482-0. CODE Unit #16LV48159. MANUFACTURER American Red Cross Blood Services, Columbus, Ohio. RECALLED BY Manufacturer, by telephone on November 3, 1999. Firm-initiated recall complete. DISTRIBUTION Ohio. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor with a history of IV drug use and incarceration. ________ PRODUCT Red Blood Cells. Recall #B-483-0. CODE Unit #1588682. MANUFACTURER Central Kentucky Blood Center, Lexington, Kentucky. RECALLED BY Manufacturer, by letter dated November 24, 1999. Firm-initiated recall complete. DISTRIBUTION Kentucky. QUANTITY 1 unit was distributed. REASON Blood product was distributed after receiving a post donation inquiry from the donor regarding test results. ________ PRODUCT Platelets, Pheresis. Recall #B-484-0. CODE Unit #01GK08941. MANUFACTURER American Red Cross Blood Services, Syracuse, New York. RECALLED BY Manufacturer, by telephone on January 27, 1999, followed by fax. Firm-initiated recall complete. DISTRIBUTION Pennsylvania. QUANTITY 1 unit was distributed. REASON Blood product did not meet the platelet yield criteria for a split product was distributed labeled as licensed. ________ PRODUCT a) Red Blood Cells; b) Recovered Plasma. Recall #B-485/486-0. CODE Unit #40FF43210. MANUFACTURER American Red Cross Blood Services, Peoria, Illinois. RECALLED BY Manufacturer, by letter dated December 17, 1999, and on December 13, 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 previously tested positive for hepatitis B. ________ PRODUCT Red Blood Cells and Recovered Plasma. Recall #B-487/488-0. CODE Unit #40GE33865. MANUFACTURER American Red Cross Blood Services, Peoria, Illinois. RECALLED BY Manufacturer, by letters dated December 3 and 10, 1999, and on or about November 30, 1999. Firm-initiated recall complete. DISTRIBUTION Missouri, Georgia, Switzerland. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor who had non-sterile ear piercing performed within 12 months of donation. ________ PRODUCT Source Plasma. Recall #B-489-0. CODE Unit #0450566151. MANUFACTURER NABI BioMedical Center, Youngstown, Ohio. RECALLED BY NABI, Boca Raton, Florida, by fax on November 24, 1999. Firm-initiated recall complete. DISTRIBUTION England. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who previously reported a blood/body fluid exposure. ________ PRODUCT a) Red Blood Cells; b) Platelets. Recall #B-490/491-0. CODE Unit Numbers a) 16LW34386, 16LW33088, 16LW31634; b) 16LW34386 and 16LW31634. MANUFACTURER American Red Cross Blood Services, Columbus, Ohio. RECALLED BY Manufacturer, by letter dated December 7, 1999. Firm-initiated recall complete. DISTRIBUTION Ohio and Alabama. QUANTITY a) 3 units; b) 2 units were distributed. REASON Blood products were collected from a donor who traveled to an area considered endemic for malaria. ________ PRODUCT Red Blood Cells. Recall #B-492-0. CODE Unit Numbers: W66145 and W86808. MANUFACTURER Aurora Area Blood Bank, Aurora, Illinois. RECALLED BY Manufacturer, by telephone on March 3, 1999. Firm-initiated recall complete. DISTRIBUTION Illinois. QUANTITY 2 units were distributed. REASON Blood products which were not tested for the C antigen and were labeled C negative. ________ PRODUCT Red Blood Cells. Recall #B-493-0. CODE Unit #N02433. MANUFACTURER Central California Blood Center, Fresno, California. RECALLED BY Manufacturer, who recovered the unit from the consignee on May 17, 1998. Firm-initiated recall complete. DISTRIBUTION California. QUANTITY 1 unit was distributed. REASON Blood product was positive for the C and e antigens but was labeled negative for C and e. ________ PRODUCT Red Blood Cells. Recall #B-494-0. CODE Unit #3482621. MANUFACTURER Gulf Coast Regional Blood Center, Houston, Texas. RECALLED BY Manufacturer, by telephone on October 12, 1998. Firm-initiated recall complete. DISTRIBUTION Texas. REASON Blood product tested positive for the Fyb antigen was labeled Fyb negative. ________ PRODUCT Fresh Frozen Plasma. Recall #B-496-0. CODE Unit Numbers: 18215-4179, 18215-4193, 18215-4195. MANUFACTURER United Blood Services, Cheyenne, Wyoming. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by telephone on October 21, 1998, followed by letter dated November 23, 1998. Firm-initiated recall complete. DISTRIBUTION Nebraska. QUANTITY 3 units were distributed. REASON Blood products may have been incorrectly tested for unexpected antibodies. ________ PRODUCT Red Blood Cells. Recall #B-498-0. CODE Unit Numbers: 31019422, 31019436, 32011129, 32011211, 32011326, 34022244, 10017580, 31019541, 11013776, 31019496, 13002078, 13002083, 34022297, 34022300, 31019371, 34021960. MANUFACTURER W.E. and Lela I. Stewart Blood Center, Inc., Tyler, Texas. RECALLED BY Manufacturer, by letter dated June 29, 1999. Firm-initiated recall complete. DISTRIBUTION Texas. QUANTITY 16 units were distributed. REASON Blood products were stored at unacceptable temperatures. ________ PRODUCT Platelets. Recall #B-499-0. CODE Unit #7778558. MANUFACTURER LifeSource, Glenview, Illinois. RECALLED BY Manufacturer, by telephone on August 12, 1999. Firm-initiated recall complete. DISTRIBUTION Illinois. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who had traveled to an area designated as endemic for malaria. ________ PRODUCT Platelets and Fresh Frozen Plasma. Recall #B-500/501-0. CODE Unit #L62997. MANUFACTURER Northern Illinois Blood Bank, Rockford, Illinois. RECALLED BY Manufacturer, by telephone on November 16, 1999, and by letter dated November 24, 1999. Firm-initiated recall complete. DISTRIBUTION Illinois. QUANTITY 1 unit of each component was distributed. REASON Blood products corresponded to a unit of Red Blood Cells that were implicated in a transfusion reaction and was found to be contaminated with coagulase negative Staphylococcus, and Streptococcus. ________ PRODUCT a) Red Blood Cells; b) Platelets, Pooled; c) Fresh Frozen Plasma. Recall #B-502/504-0. CODE Unit Numbers: a) 9987170; b) 0066783; c) 9987170. MANUFACTURER Hoxworth Blood Center, University of Cincinnati Medical Center, Cincinnati, Ohio. RECALLED BY Manufacturer, by letter dated March 29, 1999. Firm-initiated recall complete. DISTRIBUTION Ohio. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from an unsuitable donor.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
________ PRODUCT English Plantain, Allergenic Extract, 50 mL. Recall #B-410-0. CODE Lot #J99H1718. MANUFACTURER Hollister-Steir Laboratories, Inc., Spokane, Washington. RECALLED BY Manufacturer, by telephone and letter on January 5, 2000. Firm-initiated recall complete. DISTRIBUTION California, Illinois, and Missouri. QUANTITY 3 vials were distributed. REASON Allergenic extracts were labeled with extended expiration dates. ________ PRODUCT Platelets Pheresis, Leukocytes Reduced. Recall #B-422-0. CODE Unit Numbers: 01P40614 (split unit), 01P40618, 01P40621. MANUFACTURER American Red Cross Blood Services, Rochester, New York. RECALLED BY Manufacturer, by letter dated May 14, 1999. Firm-initiated recall complete. DISTRIBUTION New York. QUANTITY 2 units and 1 split unit. REASON Unlicensed blood products were distributed in intrastate commerce without obliteration of the firmís license number. ________ PRODUCT Red Blood Cells, Irradiated. Recall #B-423-0. CODE Unit Numbers: KM47107 and KQ47808. MANUFACTURER Virginia Blood Services, Richmond, Virginia. RECALLED BY Manufacturer, by telephone on March 23, 1999. Firm-initiated recall complete. DISTRIBUTION Virginia. QUANTITY 2 units were distributed. REASON Blood products were labeled with an extended expiration date. ________ PRODUCT Platelets, Pheresis. Recall #B-427-0. CODE Unit #W60381. MANUFACTURER Virginia Blood Services, Richmond, Virginia. RECALLED BY Manufacturer, by letter dated August 2, 1999. Firm-initiated recall complete. DISTRIBUTION Virginia. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor whose arm inspection had not been documented. ________ PRODUCT Fresh Frozen Plasma Pheresis. Recall #B-466-0. CODE Unit #W61272. MANUFACTURER Virginia Blood Services, Richmond, Virginia. RECALLED BY Manufacturer, by letter dated November 9, 1999. Firm-initiated recall complete. DISTRIBUTION Virginia. QUANTITY 1 unit was distributed. REASON Blood product was not frozen within six hours of collection. ________ PRODUCT Platelets Pheresis, Leukocytes Reduced. Recall #B-471-0. CODE Unit #01FP07976. MANUFACTURER American Red Cross Blood Services, Syracuse, New York. RECALLED BY Manufacturer, by letter dated May 7, 1999. Firm-initiated recall complete. DISTRIBUTION New York. QUANTITY 1 unit was distributed. REASON Unlicensed blood product was distributed in intrastate commerce without obliteration of the firmís license number. ________ PRODUCT Corneas. Recall #B-472-0. CODE Tissue Numbers 99522OD and 99522OS. MANUFACTURER Upstate New York Transplant Services, Buffalo, New York. RECALLED BY Manufacturer, by telephone on December 28, 1999, and by letter dated December 30, 1999, and January 4, 2000. Firm-initiated recall complete. DISTRIBUTION Georgia. QUANTITY 2 corneas were distributed. REASON Corneas were collected from a donor who tested repeatedly reactive for HIV ½, with a negative Western Blot test and no HIV-DNA-PCR detected. ________ PRODUCT Red Blood Cells. Recall #B-495-0. CODE Unit Numbers: 13GR03041 and 13LG51528. MANUFACTURER American Red Cross Blood Services, Detroit, Michigan. RECALLED BY Manufacturer, by letter dated September 28, 1998. Firm-initiated recall complete. DISTRIBUTION Michigan. QUANTITY 2 units were distributed. REASON Blood products were incorrectly tested for the Cw antigen and were labeled Cw negative.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
________ PRODUCT APLIGRAF (GRAFTSKIN) Apligraf is indicated for use with standard therapeutic compression for the treatment of non-infected partial or full-thickness skin ulcers. Recall #Z-416-0. CODE Packaging run GS991109.03.2A. Unit Numbers: 35, 36, 37, 39, 40, 41, 42, 43, 44, 45, 48, 49, 50, 51, 52, 53, 54, 55, 56, 58, 59, 60, 61, 63, 64, 65, 66, 67, 68, 69, 70 and 71. MANUFACTURER Organogenesis, Inc., Canton, Massachusetts. RECALLED BY Manufacturer, by letter sent on December 15, 1999. Firm-initiated recall complete. DISTRIBUTION Arizona, Florida, Georgia, Illinois, Indiana, Louisiana, Maryland, Michigan, Minnesota, North Carolina, Ohio, Oklahoma, Pennsylvania, Texas. QUANTITY 32 units were distributed. REASON Product was contaminated with Burkholderia cepecia. ________ PRODUCT Servo Ventilator 300 and Servo Ventilator 300A, an intensive care ventilator that can be used on patients ranging from neonates to adults. Recall #Z-417/418-0. CODE Siemens Servo Ventilator 300 and Servo Ventilator 300A Codes: Model 300/300A: Serial Number 2757 to 16348 Codes: Model 300/300A: Serial Number: 8830 and higher. MANUFACTUER Siemens-Elema AB, Solna, Sweden. RECALLED BY Siemens Medical Systems, Inc., Danvers, Massachusetts, by letter on February 3, 2000. Firm-initiated field correction ongoing. DISTRIBUTION Nationwide. QUANTITY 5,200 units were distributed. REASON Higher trigger sensitivity than expected in neonate setting and frozen alpha value. ________ PRODUCT Stryker Endoscopy Cholangiogram Kit, a catheter used to introduce dye into the common bile duct to facilitate an X-ray to check for bilestones. Recall #Z-419-0. CODE 250-10-430. MANUFACTURER Stryker Endoscopy, Santa Clara, California. RECALLED BY Manufacturer, by letter on February 14, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY 1,522 units were distributed. REASON Failure to include latex and natural rubber disclosure statement. ________ PRODUCT Biolaser, used for biostimulation: a) Model 1000; b) Model 2000. Recall #Z-421/422-0. CODE Models 1000 and 2000. MANUFACTURER Bio-Laser Response Corporation, Castle Rock, Colorado. RECALLED BY Manufacturer. FDA approved the firm's corrective action plan on March 2, 2000. Firm-initiated field correction ongoing. DISTRIBUTION Nationwide. QUANTITY a) 3 units; b) 6 units were distributed. REASON The devices are adulterated, misbranded, and failed to comply with 21 CFR 1040.10 and 11 in that the models have numerous noncompliance. ________ PRODUCT Mechanical Wheelchair. Recall #Z-428-0. CODE XTR-4586 sold between 11/05/98 and 01/10/00. MANUFACTURER Sunrise Medical Inc., Fresno, California. RECALLED BY Manufacturer, by letter February 28, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY 756 units were distributed. REASON Poor design - User can fall backwards and there is potential for injury. ________ PRODUCT Allograft Heart Valves: Model PV05, PV00 and AV05. Recall #Z-435/436-0. CODE Serial Numbers - 6150896, 6305342, and 6309992. MANUFACTURER Cryolife, Inc., Kennesaw, Georgia. RECALLED BY Manufacturer, by letter sent on February 21, 2000. Firm-initiated recall ongoing. DISTRIBUTION Texas, West Virginia, Germany. QUANTITY 3 valves were distributed. REASON Donors did not meet current guidelines regarding serodilution of plasma. ________ PRODUCT Allograft Heart Valve, Model PV05. Recall #Z-437-0. CODE Serial Numbers: 6268404 and 6310001. MANUFACTURER Cryolife, Inc., Kennesaw, Georgia. RECALLED BY Manufacturer, by telephone on February 15 and 18, 2000. Firm-initiated recall ongoing. DISTRIBUTION Washington state and Texas. QUANTITY 2 valves. REASON Donors did not meet current guidelines regarding serodilution of plasma. ________ PRODUCT Allograft Heart Valve, Models PV00 and AV00. Recall #Z-438/439-0. CODE Serial Numbers: 6668691 and 6668704. MANUFACTURER Cryolife, Inc., Kennesaw, Georgia. RECALLED BY Manufacturer, by telephone on February 8 and 9, 2000. Firm-initiated recall ongoing. DISTRIBUTION Arizona and New Jersey. QUANTITY 2 valves. REASON Donors did not meet current guidelines regarding serodilution of plasma. ________ PRODUCT Human Heart Valves, frozen and processed for transplantation. Recall #Z-440-0. CODE 52 human heart valves uniquely identified by a 10-digit alpha-numeric code. MANUFACTURER Lifenet, Virginia Beach, Virginia. RECALLED BY Manufacturer, by letter on January 24, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 52 valves. REASON Sera from donors of human tissues were not tested using validated methods.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
________ PRODUCT IntraStent Biliary Endoprosthesis, 36 mm in length. The product was labeled for foreign distribution as IntraStent Peripheral Stent, 36 mm in length, Product Number S10-36 on both labels, intended for permanent implant. Recall #Z-420-0. CODE Lot 19931207 of the Biliary Endoprosthesis, and lot 19933703 of the Peripheral Stents. MANUFACTURER Intratherapeutics, Inc., St. Paul, Minnesota. RECALLED BY Manufacturer, by letter dated February 18, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY 128 stents were distributed. REASON The stent length was incorrectly identified on the product labels as 36mm, rather than the actual length of 26 mm. ________ PRODUCT Trocar Needle for use in interstitial treatment prior to brachytherapy of patient: Part Numbers: 083.914, 083.918, 083.920, 083.922, 083.924, 083.926. Recall #Z-429/434-0. CODE Lot numbers 480505 to 481130. MANUFACTURER Nucletron BV, The Netherlands. RECALLED BY Nucletron Corporation, Columbia, Maryland, by mail on December 13, 1999. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 654 devices were distributed. REASON Tip of trocar needle separated from body of needle leaving tip in the patient.RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS II
________ PRODUCT Erythromycin Phosphate bulk drug substance, intended for the manufacture of various veterinary antibiotics for the treatment of respiratory infections in cattle, swine and sheep. Recall #V-065-0. CODE 27919 - List #27919-29-06, List #05151-04-05, List #05151-04-11 41988 - List #05302-04-01. Product Code 27919, Lot Numbers and EXP Dates: 84537E5 01/01/1995 84756CD 07/01/1995 84721CD 01/01/1995 87155CD 04/01/1996 90546CD 07/01/1996 90567CD 07/01/1996 90608CD 07/01/1996 90644CD 12/01/1995 91683CD 08/01/1996 91782CD 08/01/1996 92817CD 09/01/1996 92850CD 09/01/1996 93042CD 10/01/1996 93071CD 10/01/1996 94095CD 07/01/1996 95219CD 12/01/1996 95251CD 12/01/1996 95291CD 12/01/1996 95324CD 12/01/1996 95356CD 12/01/1996 96421CD 01/01/1996 03920CD 04/01/1997 04012CD 05/01/1997 04952CD 05/01/1997 04983CD 05/01/1997 11622E5 05/01/1997 11884CD 12/01/1997 11950CD 12/01/1997 13245CD 08/01/1997 13627E5 02/01/1998 16610CD 05/01/1998 16642CD 05/01/1998 16674CD 05/01/1998 16737CD 05/01/1998 17793CD 12/01/1998 17869CD 06/01/1998 17909CD 06/01/1998 18944CD 07/01/1998 21526CD 10/01/1998 21561CD 10/01/1998 22661CD 11/01/1998 22702CD 11/01/1998 22737CD 11/01/1998 23656E5 03/01/1998 26234AK 11/01/1998 26235AK 10/01/1998 26335CD 03/01/1999 27469CD 04/01/1999 27496CD 04/01/1999 28528CD 05/01/1999 31023CD 08/01/1999 31024CD 08/01/1999 31025CD 08/01/1999 31685E5 08/01/1999 34433CD 11/01/1999 34434CD 11/01/1999 34435CD 11/01/1999 34437CD 11/01/1999 34438CD 11/01/1999 35715CD 10/01/1999 37983CD 02/01/2000 38100CD 03/01/2000 38136CD 3/01/2000 38137CD 03/01/2000 38175CD 03/01/2000 38176CD 03/01/2000 39210CD 04/01/2000 39253CD 04/01/2000 39254CD 04/01/2000 39289CD 04/01/2000 39290CD 04/01/2000 39324CD 10/01/1999 40404CD 05/01/2000 40405CD 05/01/2000 Product Code 041988, Lot Numbers and EXP Dates: 87123CD 04/01/1996 87543E5 01/01/1996 89431CD 05/01/1996 92883CD 09/01/1996 93042CD 10/01/1996 96388CD 01/01/1996 14410CD 03/01/1998 27394CD 04/01/1999 37023CD 02/01/2000 MANUFACTURER Abbott Laboratories, Chemical Agricultural Products Division, North Chicago, Illinois. RECALLED BY Manufacturer, by letter on February 29, 1999. Firm-initiated recall ongoing. DISTRIBUTION California, Kansas, Maryland, Washington state, Arizona, Texas, New Jersey, Connecticut, Arkansas, Canada. QUANTITY 74 lots (54,000 kg est.) of product code 027919 and 9 lots (6,500 kg est.) of product code 041988 of bulk drug substance were distributed between 2/16/94 and 11/20/98. The amount remaining on the market is unknown. REASON The bulk drug substance may not maintain adequate potency prior to the 60-month expiration date. ________ PRODUCT Pen-Aqueous, Penicillin G Procaine Injectable Suspension USP 300,000 units per ml. - 250 ml and 500 ml bottles. Recall #V-080-0. CODE RXV 250 - Lot 9085-06 RXV 250 - Lot 9131-01 RXV 500 - Lot 9051-01 RXV 500 - Lot 9061-01 RXV 500 - Lot 9091-01 RXV 500 - Lot 9091-02 RXV 500 - Lot 9091-03 RXV 500 - Lot 9092-01 AGP 250 - Lot 9044-01. MANUFACTURER Norbrook Laboratories, Ltd., Newry, County Down, Northern Ireland (responsible firm). RECALLED BY Rx Veterinary Products, Kansas City, Missouri, by fax and letter on December 9, 1999. Firm-initiated recall complete. DISTRIBUTION Minnesota, Virginia, Ohio, Colorado, Oklahoma, Indiana, Arizona, California, Idaho, Washington state, Texas, Michigan, Pennsylvania, South Dakota. QUANTITY 23,624 250-ml bottles and 22,953 500-ml bottles were distributed. REASON Bottles may contain glass particles.END OF ENFORCEMENT REPORT FOR MARCH 15, 2000. ####
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