FDA

Enforcement Report

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


November 24, 1999                                                   99-47

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I

________ PRODUCT Blue Ribbon brand a) Whitefish Salad in 8 ounce plastic tubs; b) Baked Salmon Salad in 8 ounce plastic tubs. Recall #F-054/055-0. CODE Both products are coded SELL BY 1008 and have a batch code of 236 on a separate label on the bottom of the container. MANUFACTURER Blue Ribbon Smoked Fish Company, Brooklyn, New York. RECALLED BY Manufacturer, by telephone, letter and fax on September 17, 1999. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION New York and New Jersey. QUANTITY A total of 300 8-ounce packages of White Fish Salad and 111 8-ounce packages of Baked Salmon Salad were distributed; Firm estimates none remains on the market. REASON Products were contaminated with Listeria monocytogenes.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS I

________ PRODUCT a) Ana-KitÆ Anaphylaxis Emergency Treatment Kit- consisting of 1 syringe (1.0 mL) containing two single doses (0.3 mL) of Epinephrine Injection USP, (1:1000), 4 tablets (Chlorpheniramine Maleate) of antihistamine, and 2 sterile isopropyl alcohol (70%) swabs, labeled in part "Pkgd. and Dist. By: Bayer Corporation Pharmaceutical Division Spokane, WA 99207 ** Epinephrine Mfg by: Wyeth-Ayerst Laboratories Philadelphia, PA 19101***", for treatment of severe anaphylactic or anaphylactoid reactions and severe asthma. Sold as individual kits or 6-packs. NDC 0026-9988-01 and 0026-9988-06; b) Ana-GuardÆ Epinephrine Injection USP (1:1000)- consisting of 1 syringe (1.0 mL) containing two single doses (0.3 mL) of Epinephrine Injection USP, (1:1000). labeled in part "ANA-GUARD EPINEPHRINE INJECTION, USP (1:1000) ** Pkgd. and Dist. By: Bayer Corporation Pharmaceutical Division Spokane, WA 99207 USA Epinephrine Mfg. By: Wyeth-Ayerst Laboratories Philadelphia, PA 19101***. NDC 0026-9984-01 and 0026-9984-06; c) Epinephrine Injection, USP (1:1,000) Syringe - a refill item for the above two products sold as 500 syringes/box under NDC# 0026-9982-01 each containing two single doses (0.3 mL) of Epinephrine Injection USP, (1:1000). Recall #D-059/061-0. CODE Ana-Kit: AK344 EXP Date 8-99 AK345 EXP Date 8-99 AK346 EXP Date 9-99 AK347 EXP Date 11-99 AK348 EXP Date 1-2000 AK349 EXP Date 5-2000 AK350 EXP Date 9-99 AK351 EXP Date 11-99 AK352 EXP Date 9-99 AK353 EXP Date 5-2000 AK354 EXP Date 6-2000 AK355 EXP Date 6-2000 AK356 EXP Date 7-2000 AK357 EXP Date 9-99 AK358 EXP Date 1-2000 AK359 EXP Date 8-2000 AK360 EXP Date 9-99 AK361 EXP Date 9-99 AK362 EXP Date 11-99 AK363 EXP Date 1-2000 AK366 EXP Date 7-2000 Ana-Guard: G00196 thru G00203 (inclusive) EXP Date September 1999 G00204 & G00205 EXP Date November 1999 G00206, G00207, G00208 EXP Date January 2000 G00209 EXP Date May 2000 G00210 EXP Date June 2000 G00211, G00212, G00213 EXP Date July 2000 G00214 through G00220 (inclusive), G00222, G00223 EXP Date August 2000 Epinephrine Injection Refills: S315 EXP Date Aug 1999 S316 through S320 (inclusive) EXP Date Sept 1999 S321, S322, S323 EXP Date Nov. 1999 S324 through S327 (inclusive) EXP Date Jan 2000 S328 through S333 (inclusive) EXP Date May 2000 S334, S335, S336 EXP Date July 2000 S337 through S340 (inclusive) EXP Date Aug 2000. MANUFACTURERS Epinephrine: Wyeth-Ayerst Laboratories, Philadelphia, Pennsylvania (responsible firm); Ana-Kit and Ana-Guard: Hollister-Stier Laboratories LLC, Spokane, Washington (formerly a Bayer Corporation Pharmaceutical Division Company). RECALLED BY Hollister-Stier Laboratories LLC., Spokane, Washington, by letters dated August 24, 25,and 30, 1999, and by fax on August 24, 1999. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY Ana-Kit: 456,036 kits were distributed Ana-Guard: 55,238 kits were distributed Refills: 62,027 distributed REASON Subpotency of the Epinephrine. ________ PRODUCT DERM/BURO INSECT STING KIT, Rx - consisting of 1 syringe (1.0 mL) containing two single doses (0.3 mL) of Epinephrine Injection USP, (1:1000), 4 chewable tablets (Chlorpheniramine Maleate) of antihistamine, 2 sterile isopropyl alcohol (70%) swabs and one tourniquet. Per label: "Pkgd. and Dist. by: Derm/Buro Inc., Deerfield, IL 60015". Recall #D-062-0. CODE Derm/Buro KIT Lot #/EXP Date Epinephrine Lot #/EXP Date (in Kit) #0397, 11/99 2971529, 11/99 #0497, 11/99 2971529, 11/99 #0497, 02/00 2971534, 02/00 #0597, 02/00 2971534, 02/00 #8141, 02/00 2971534, 02/00 #8141, 05/00 2971538, 05/00 #8139, 05/00 2971538, 05/00 #11464, 05/00 2971538, 05/00 #11464, 05/00 2983265, 07/00 #13239, 05/00 2983265, 07/00. MANUFACTURER Wyeth Ayerst Laboratories, West Chester, Pennsylvania (maker of Epinephrine/responsible firm). RECALLED BY Derm/Buro, Inc., Plainview, New York (distributor of sting kit), by letter dated August 23, 1999. Firm-initiated recall ongoing. DISTRIBUTION U.S. government military installations nationwide. QUANTITY 59,964 kits were distributed. REASON Subpotency of the Epinephrine. ________ PRODUCT Epinephrine Injection, USP, 1:1000, Rx, in 1 mg/1 mL Tubex Æ syringes, (25 gauge 5/8 inch needle) units of 10, used to treat respiratory distress in bronchial asthma or during severe, acute asthma attacks, reversible bronchospasms, severe acute anaphylactic reactions, cardiac arrest - to restore cardiac rhythm, and hypersensitivity reactions to drugs, sera, insect stings or other allergens. (NDC# 0008-0263-01) and 50 (NDC# 0008- 0263-02). Recall #D-063-0. CODE NDC 0008-0263-01 - Lots: 2971529 EXP 11/99, 2971530 EXP 9/99, 2971534 EXP 2/00, 2971535 EXP 3/00, 2971536 EXP 4/00, 2971538 EXP 5/00, EXP 2983265 EXP 7/00. NDC 0008-0263-02 - Lots: 2971525 EXP 8/99, 2971526 EXP 9/99, 2971531 EXP 11/99, 2971533 EXP 1/00, 2971537 EXP 5/00, 2983255 EXP 6/00, 2983256 EXP 7/00, and 2983257 EXP 8/00. MANUFACTURER Wyeth Ayerst Laboratories, West Chester, Pennsylvania. RECALLED BY Wyeth Ayerst Research, inc., Radnor, Pennsylvania, by letter dated August 19, 1999. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and Sweden. QUANTITY 516,610 tubex/syringes of NDC 0008-0263-01 and 651,600 tubex/syringes of NDC 0008-0263-02 were distributed. REASON Subpotency.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

________ PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma; d) Recovered Plasma. Recall #B-034/037-0. CODE Unit Numbers: a) 04H71124, 04J96323; b) 04H71124, 04J96323; c) 04H71124; d) 04J96323. MANUFACTURER American Red Cross, Dedham, Massachusetts. RECALLED BY Manufacturer, by letter dated June 11 or 21, 1999, or fax on June 15, 1999. Firm-initiated recall complete. DISTRIBUTION New York, Maine, Massachusetts, California. QUANTITY a) 2 units; b) 2 units; c) 1 unit; d) 1 unit. REASON Blood products were collected from an unsuitable donor. ________ PRODUCT a) Red Blood Cells; b) Platelets; c) Recovered Plasma. Recall #B-117/119-0. CODE Unit Numbers: a) 22LQ61516, 22GZ73653; b) 22LQ61516; c) 22LQ61516. MANUFACTURER American National Red Cross, Philadelphia, Pennsylvania. RECALLED BY Manufacturer, by letters dated April 15, 1998 or December 11, 1998, and by telephone on April 10, 1998, or December 1, 1998. Firm-initiated recall complete. DISTRIBUTION Pennsylvania and California. QUANTITY 1 unit of each component was distributed. REASON Blood products were not quarantined after receiving information concerning a post donation illness. ________ PRODUCT a) Red Blood Cells; b) Cryoprecipitated AHF. Recall #B-126/127-0. CODE Unit #30GH25982. MANUFACTURER American National Red Cross, Ashley, Pennsylvania. RECALLED BY Manufacturer, by letter dated March 13, 1998, and by telephone on March 6, 1998. Firm-initiated recall complete. DISTRIBUTION Pennsylvania and Massachusetts. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor diagnosed with Mycosis Fungoides. ________ PRODUCT Red Blood Cells, Leukoreduced. Recall #B-129-0. CODE Unit #03KQ06498. MANUFACTURER American Red Cross Blood Services, Savannah, Georgia. RECALLED BY Manufacturer, by telephone on March 30, 1999, and by letter dated April 15, 1999. Firm-initiated recall complete. DISTRIBUTION Georgia. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who had been deferred for a history of antibiotic therapy. ________ PRODUCT a) Red Blood Cells; b) Platelets; c) Plamsa, Cryoreduced; d) Cryoprecipitated AHF; e) Recovered Plasma. Recall #B-132/136-0. CODE Contact FDA, Center for Biologics Evaluation and Research, Office of Compliance (301) 827-6220 for individual unit numbers recalled. MANUFACTURER American Red Cross Blood Services, Rochester, New York. RECALLED BY Manufacturer, by letters dated August 14 or 17, 1998, September 25, 1998, and in November 1998. Firm-initiated recall complete. DISTRIBUTION New York, Pennsylvania, Florida. QUANTITY a) 39 units; b) 23 unit; c) 1 unit; d) 1 unit; e) 32 units were distributed. REASON Blood products that were not tested for syphilis and unexpected antibodies. ________ PRODUCT Platelets, Pheresis, Leukocytes Reduced. Recall #B-137-0. CODE Unit #19235-6429. MANUFACTURER United Blood Services, Reno, Nevada. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by letter dated June 23, 1998. Firm-initiated recall complete. DISTRIBUTION California. QUANTITY 1 unit was distributed. REASON Blood product was mislabeled as CMV antibody negative. ________ PRODUCT a) Red Blood Cells; b) Platelets; c) Recovered Plasma. Recall #B-139/141-0. CODE Unit #19021-5133. MANUFACTURER United Blood Services, Reno, Nevada. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by letter dated December 17, 1998, or by fax on December 18, 1998. Firm- initiated recall complete. DISTRIBUTION Illinois, Nevada, Switzerland. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor who had previously been deferred after requesting that a donation be identified for confidential self exclusion. ________ PRODUCT Red Blood Cells. Recall #B-142-0. CODE Unit Numbers: 0467203, 0467181, 0123666, 0123842. MANUFACTURER Euroblood Center, Amsterdam, Netherlands. RECALLED BY New York Blood Services (Center West), New York, New York, by letter dated September 14, 1999. Firm-initiated recall complete. DISTRIBUTION New Jersey and New York. QUANTITY 4 units were distributed. REASON Blood products were collected from donors who previously tested reactive for syphilis within one year of donation. ________ PRODUCT Platelets. Recall #B-144-0. CODE Unit #22KR45359. MANUFACTURER American National Red Cross, Philadelphia, Pennsylvania. RECALLED BY Manufacturer, by letter dated March 24, 1999. Firm-initiated recall complete. DISTRIBUTION New Jersey. QUANTITY 1 unit was distributed. REASON Blood product corresponded to a unit of clotted red blood cells.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

________ PRODUCT a) Whole Blood; b) Red Blood Cells; c) Red Blood cells, Leukocytes Reduced; d) Fresh Frozen Plasma; e) Platelets; f) Platelets, Pheresis; g) Recovered Plasma; h) Recovered Plasma for further Manufacturing of Non-Injectable Products; i) Red Blood Cells for Further Manufacturing. Recall #B-090/098-0. CODE Contact FDA, Center for Biologics Evaluation and Research, Office of Compliance (301) 827-6220 for individual unit numbers recalled MANUFACTURER American Red Cross Blood Services, Cleveland, Ohio. RECALLED BY Manufacturer, by telephone on June 26, 1998, July 13 and 14, 1998, and/or by letters on July 17 and 21, 1998. Firm-initiated recall complete. DISTRIBUTION Ohio, Michigan, Idaho, Missouri, California, Switzerland. QUANTITY a) 1 unit; b) 186 units; c) 52 units; d) 151 units; e) 161 units; f) 31 units; g) 78 units; h) 22 units; i) 6 units were distributed. REASON Blood products were not tested for the HIV-1 p24 antigen in accordance with the test kit manufacturer's instructions. ________ PRODUCT a) Red Blood Cells; b) Red Blood Cells, Leukocytes Reduced; c) Platelets; d) Platelets, Pheresis; e) Cryoprecipitated AHF; f) Plasma, Cryo Poor; g) Recovered Plasma; h) Red Blood Cells for Manufacturing Use Only; i) Recovered Plasma Liquid For Manufacturing Non-Injectable; j) Platelets for Use in Manufacturing Non-Injectable Products. Recall #B-107/116-0. CODE Unit Numbers: a) 249279, 265000, 291998, 298140, 348672 b) 334033; c) 249279, 265000, 298140, 334033, 348672 d) 207400, 218802, 226184, 232371, 243800, 251608, 342920, 346872; e) 291998; f) 291998; g) 249279, 265000, 298140, 334033, 348672, 207400, 243800, 346872; h) 278812; i) 185666, 194326, 194936, 196973, 197389, 197593, 198549; j) 196973, 268911, 278812, 323836. MANUFACTURER Memorial Blood Centers of Minnesota, Minneapolis, Minnesota. RECALLED BY Manufacturer, by letters dated June 15, 21, 28, 1999, and August 9, 1999. Firm-initiated recall complete. DISTRIBUTION California, Florida, Minnesota, New Jersey, Pennsylvania, Switzerland. QUANTITY a) 5 units; b) 1 unit; c) 5 units; d) 8 units; e) 1 unit; f) 1 unit; g) 8 units; h) 1 unit; i) 7 units; j) 4 units were distributed. REASON Blood products tested negative for the antibody to the human immunodeficiency virus type 1/2 (anti-HIV-1/2), but were collected from donors who previously tested repeatedly reactive for anti-HIV-2. ________ PRODUCT Recovered Plasma. Recall #B-128-0. CODE Unit #30GH25982. MANUFACTURER American National Red Cross, Ashley, Pennsylvania. RECALLED BY Manufacturer, by questionable plasma inquiry forwarded on March 11, 1998. Firm-initiated recall complete. DISTRIBUTION Switzerland. QUANTITY 1 unit was distributed. REASON Blood products were collected from a donor diagnosed with Mycosis Fungoides. ________ PRODUCT Platelets, Pheresis, Leukocytes Reduced. Recall #B-130-0. CODE Unit #19236-2697. MANUFACTURER United Blood Services, Reno, Nevada. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by letter dated September 14, 1999. Firm-initiated recall complete. DISTRIBUTION Nevada. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who had an elevated body temperature. ________ PRODUCT Red Blood Cells, Leukocytes Reduced. Recall #B-138-0. CODE Unit Numbers: 16333-7131, 16333-7132, 16333-7133, 16333-7134, 16334-5938, 16340-5551, 16340-5896, 16340-5897, 16340-5899, 16340-5900, 16340-5901, 16340-6282, 16340-7565, 16340-8695, 16340-8708, 16341-3035, 16341-3100, 16341-3102, 16341-3104, 16342-0096, 16342-0097, 16342-0098, 16342-0099, 16342-0101, 16342-0352, 16342-8743, 16343-6682, 16343-6683, 16343-6684, 16343-6685, 16343-6687, 16343-8624, 16343-8626, 16344-2112, 16344-2113, 16344-3545, 16344-3041, 16344-3042, 16344-3043, 16344-4445, 16344-4446, 16344-4447, 16344-9258, 16344-9259, 16344-9261. MANUFACTURER Blood Systems, Inc., Meridian, Mississippi. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by telephone on September 18, 1998, and/or letter dated October 1, 1998. Firm- initiated recall complete. DISTRIBUTION Mississippi. QUANTITY 45 units were distributed. REASON Red Blood Cells, leukoreduced by filtration greater than 72 hours past the time of collection, were distributed for transfusion. ________ PRODUCT Red Blood Cells, Irradiated, Low Volume. Recall #B-145-0. CODE Unit Numbers: 22LY61409, 22LQ68923, 22LQ69111, 22KC06664, 22KY29843. MANUFACTURER American National Red Cross, Philadelphia, Pennsylvania. RECALLED BY Manufacturer, by telephone and by fax on March 26, 1999. Firm- initiated recall complete. DISTRIBUTION Pennsylvania. QUANTITY 5 units were distributed. REASON Blood products were labeled with extended expiration dates. ________ PRODUCT Red Blood Cells. Recall #B-205-0. CODE 26159-4806, 26159-4808, 26159-4814. MANUFACTURER United Blood Services, Fort Smith, Arkansas. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by telephone on September 13, 1999. And by letter dated September 21, 1999. Firm-initiated recall complete. DISTRIBUTION Arkansas and Oklahoma. QUANTITY 3 units were distributed. REASON Blood products were labeled with extended expiration dates.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

________ PRODUCT Stealth Surgical Clamps, indicated for surgical clamping during cardiovascular, peripheral vascular, and general surgery: a) Model No. A3220; Model No. A3219. Recall #Z-207/208-0. CODE a) Lot Nos. E9C012, E9C083, E9C084, 99E040, 99E419; b) Lot Nos. E9C014, E9C015, E9C087, 99F476, 99E418, 99E417. MANUFACTURER Applied Medical Resources, Laguna Hills, California. RECALLED BY Manufacturer, by fax on August 11, 1999, and by voice mail. Firm-initiated recall ongoing. DISTRIBUTION Michigan, Mississippi, New York, Ohio, Texas. QUANTITY a) 71 clamps; b) 418 clamps were distributed. REASON The clamps have a potential for misalignment under high pressure which could cause the clamps to release prematurely or to tear the tissue held by the clamp. ________ PRODUCT Nellcor Puritan Bennett 740 Ventilator and 760 Ventilator System. Recall #Z-209/210-0. CODE All ventilators that operate at the consignee at a main voltage of 110v. MANUFACTURER Nellcor Puritan Bennett Ireland, Galway, Ireland. RECALLED BY Mallinckrodt, Inc., St. Louis, Missouri, by letter dated September 24, 1999. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY 2,359 ventilators were distributed. REASON Battery power can deplete when power supply switches voltage due to spikes.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III

________ PRODUCT Spinal Anesthesia Tray, a sterile, disposable, single use device for the administration of spinal anesthesia. Recall #Z-206-0. CODE Catalog #407225, Lot #8H300 EXP 8/99. MANUFACTURER North American Sterilization and Packaging, Franklin, New Jersey. RECALLED BY Becton Dickinson Anesthesia Systems, Franklin Lakes, New Jersey, by telephone on October 9, 1998, followed by letter on November 10, 1998. Firm-initiated recall complete. DISTRIBUTION Nationwide. QUANTITY Firm estimated that 218 trays remained on market at time of recall initiation. REASON The vials of Tetracaine included on the tray has an expiration date of 4/99, while the trays are dated with an expiration of 8/99. There is a possibility that expired drug could be used resulting in ineffective anesthesia.

RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS - CLASS II

________ PRODUCT Products sold under Feedstuffs Processing Co. Label: 1. Lactation Sow Cone 2. Feed Yeast 3. E$scape 200 4. Gilbert Medicated Rumensin Pellets 5. Vitamin B Premix 6. Deccox Pellets 7. Special H/B Red Supplement 8. Special H/B Green - Chicken 9. Nufac 50 10. Modesto Milling Rumensin 11. Dog Food Supplement 12. 2:1 Calcium/Phos+ 13. l:l Supplement + No salt 14. Quam-Brodsky Dry Cow 15. Escape 60 16. 60-40 Protein Mix 17. Horse Supplement #5000 18. Natures Best Ocean Pellet Premix 19. Lawleyís Eliminator 20. Dairy Mineral 50 21. Barreto & Silveira Fresh Cow 22. Fawcett Heifer Mineral 23. Rumensin 1200 24. Berkeley Farms Protein/Buffer 25. Fawcett Prot/Min/Buffer Premix 26. G&D Diary Close Up Mineral 27. Brichetto Rumensin Premix 28. Whitney Oaks Dry Cow W/BDG 29. Triangle M Protein/Mineral 30. Rau Dairy Close-Up Mineral 31. Whitney Oaks By-Pass Protein 32. Kennedy/Buffer #2 33. Hillside/Springer Dry Cow 34. Hurtgen-Ve Dairy Min 35. Fertile Egg VTM Premix 36. E H Smith Lactation Mineral 37. Mendes Protein Buffer. Recall #V-001/037-0. CODE 1055, 17255, 24105LL, 1747, 17308, 17453, 3608, 1060 17810, 19175, 17846, 17663, 19150, 3548, 3445, 18703 17804, 16612YST, 16512, 16511, 1065, 1030, 17305 2693, 2692, 2721, 509, 19200A, 1021, 507, 506, 15035 13001, 4200, 19251, 12506, 15035. Products distributed between January 2, 1999 and July 28, 1999. MANUFACTURER Feedstuffs Processing Company, Turlock, California. RECALLED BY Manufacturer, by telephone followed by letter on August 19, 1999. Firm-initiated recall complete. DISTRIBUTION California, Nevada, Guam. QUANTITY Undetermined. REASON Products may have been contaminated with high levels of selenium.

RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS - CLASS III

________ PRODUCT Metabalance 25/45 M-8030 Medicated Hog Feed (Carbadox). Recall #V-050-0. CODE CH0609PEL. MANUFACTURER Consolidated Nutrition, Camp Hill, Pennsylvania. RECALLED BY Manufacturer, by telephone on May 6&7, 1999. Firm-initiated recall complete. DISTRIBUTION Pennsylvania and Maryland. QUANTITY 198 50-pound bags were distributed. REASON Feed was labeled to contain Carbadox, but actually contained ASP (chlortetracycline/suflamethazine/penicillin) - Feed was labeled incorrectly. END OF ENFORCEMENT REPORT FOR NOVEMBER 24, 1999.

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