April 16, 1997 97-16 RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I =========== _______________ PRODUCT Buitoni Fresco Two Cheese Basil Tortelloni, packed in 255 gram plastic round tubs. Recall #F-362-7. CODE "Best Before/Meilleur avant 97 MR 04 7020 DV4 12"; "Best Before/Meilleur avant 97 MR 11 7027 DV4 14"; and "Best Before/Meilleur avant 97 MR 18 7034 DV4 12". MANUFACTURER Nestle Food Division, Inc., Danville, Virginia. RECALLED BY Nestle USA - Food Division, Inc., Solon, Ohio, by letter on February 19, 1997. Firm-initiated recall complete. DISTRIBUTION Canada. QUANTITY 690 cases (6 tubs per case) were distributed REASON Product contained undeclared walnuts. _______________ PRODUCT Caramel Chocolate Dessert, heart-shaped pie. Recall #F-363-7. CODE All product shipped without an ingredient statement. MANUFACTURER Full Service Foods, Hillsboro, North Dakota. RECALLED BY Harry & David, Medford, Oregon, by telephone beginning on February 8, 1997, by mailgram on February 11, 1997, and by letter on February 13, 1997. Firm-initiated recall complete. DISTRIBUTION Nationwide and Canada. QUANTITY Product shipped to 220 recipients. REASON The product was shipped without an ingredient statement and contains the following allergens: pecans, egg whites, flour and dairy products (evaporated milk and whipping cream). _______________ PRODUCT Grand Bay Fresh Backfin Crabmeat. Recall #F-372-7. CODE None. MANUFACTURER Grand Bay Seafood, Inc., Grand Bay, Alabama. RECALLED BY Manufacturer, by telephone on September 9 and 12, 1996. Completed recall resulted from sample analysis and followup by the State of Alabama. DISTRIBUTION Alabama, Florida, Georgia, Louisiana, Maryland, Pennsylvania, Virginia. QUANTITY 544 pounds were distributed. REASON Product was contaminated with Listeria monocytogenes and was decomposed. _______________ PRODUCT Tropic Isle Fresh Frozen Coconut, flake grated in 6 ounce and 12 ounce poly bags. Recall #F-377-7. CODE All lots manufactured in Costa Rica. MANUFACTURER Yucatica S.A., Costa Rica. RECALLED BY Southern Frozen Foods, A Division of Curtis Burns Foods, Montezuma, Georgia, by press release on March 5, 1997, and by letter. Firm- initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY Between 18,000 and 200,000 cases (12 bags per case were distributed REASON Product may be contaminated with Listeria monocytogenes. RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II =========== _______________ PRODUCT Various donut products: (a) P/Fried Jumbo Y/R Ring (Jumbo Ring Donut), item #2108, 2.60 oz. each, 108/case, case net wt. 17.55 lbs., when received by the retail store, these donuts may be iced, glazed, or decorated prior to sale. (b) Raised Ring Donut (Ring Donut), item #2171, 2.00 oz. each, 108/case, case net wt. 13.50 lbs., when received by the retail store, these donuts may be iced, glazed, or decorated prior to sale. -2- (c) Bismarks, Unfilled, item #2172, 2.00 oz. each, 108/case, case net wt. 13.50 lbs., The retail store fills the Bismarks prior to sale. (d) Raspberry Filled Bismark, item #2173, 3.00 oz. each, 84/case, case net wt. 15.75 lbs., (e) Bismark (Bavarian Creme Filled), item #2174, 3.00 oz. each, 84/case, case net wt. 15.75, (f) French Crueller, item #2116, 1.35 oz. each, 84/case, case net wt. 7.09 lbs., (g) Bismark (Variety Pack), item #2190, 3.00 oz. each, 84/case, case net wt. 15.75 lbs., The flavors included in this are lemon, apple, and raspberry. (h) Sour Cream Cake Donut, item #2166, 2.00 oz. each, 144/case, case net wt. 18.00 lbs., (i) Blueberry Cake Donut, item #3216, 1.75 oz. each, 144/case, case net wt. 15.75 lbs., (j) Devils Food Cake Donut, item #2163, 2.00 oz. each, 144/case, case net wt. 18.00 lbs. Recall #F-352/361-7. CODE Lot numbers: (a) 0902975600, 0908976108, 0912976564, 0911976467, 0916976873, 0901975436, 0917977050 (b) 0917977051, 0912976563, 0902975601, 0908976109, 0916976872 (c) 0903975716, 0904975803, 0909976222, 0911976464 (d) 0903975718, 0904975840, 0911976466 (e) 0903975717, 0904975805, 0909976223, 0911976573, 0904975941 (f) 0905975920, 0913976703, 0915976717 (i) 0910976327; (g) 0904975804 and 0911976465 (h) 0910976326 and 0918977234 (j) 0910976328 and 0917977121. MANUFACTURER Hazelwood Farms Bakeries, Inc., Hazelwood, Missouri. RECALLED BY Manufacturer, by telephone and electronic mail on March 27, 1997, followed by fax. Firm- initiated recall ongoing. DISTRIBUTION Nationwide and Canada. QUANTITY 5,126 cases of bakery products containing 84- 144 pieces per case were distributed between March 5 and 25, 1997. REASON The products may be contaminated with hepatitis A. RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ========== _______________ PRODUCT Grand Bay brand Fresh Crabmeat, produced 09/01- 04/96: -3- (a) Claw Crabmeat; (b) Jumbo Lump Crabmeat; (c) Lump Crabmeat; (d) Cocktail Claw Fingers Crabmeat. Recall #F-373/376-7. CODE None. MANUFACTURER Grand Bay Seafood, Inc., Grand Bay, Alabama. RECALLED BY Manufacturer, by telephone on September 9, 1996. Completed recall resulted from sample analysis and followup by the State of Alabama. DISTRIBUTION Alabama, Florida, Georgia, Louisiana, Maryland, Pennsylvania, Virginia. QUANTITY (a) 899 pounds; (b) 1,255 pounds; (c) 582 pounds; (d) 1,905 pounds were distributed. REASON (a) Product was decomposed and produced under insanitary conditions that could contaminate the product with filth. Products (b), (c), and (d) were produced under insanitary conditions that could contaminate the product with filth. RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II ========== _______________ PRODUCT Minocycline HCl Capsules, USP, 50 mg and 100 mg, used as an antimicrobial, under the Schein, Duramed and Medicis labels. Recall #D-134/135-7. CODE Lot numbers: Schein label: 50 mg: All lots with exp. dates through 8/98, PLUS P6K0148 and P6K0149 100 mg: All lots with exp. dates through 8/98, PLUS P6K0142 and P6K0143 Duramed label: 50 mg: C6A0011, C6A0111, C6C0517, C6C0518 100 mg: C5M2834, C5M2844, C6C0687 Medicis label: 50 mg: All lots with exp. dates through 11/98 100 mg (bottles of 50) - All lots w/exp dates through 7/98 100 mg (bottles of 500) - All lots w/exp dates through 6/98. MANUFACTURER Danbury Pharmacal, Inc., Carmel, New York; and Danbury Pharmacal P.R., Inc., Humacao, Puerto Rico. RECALLED BY Danbury Pharmacal, Inc., Brewster, New York, by letter on February 26, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and Chile. QUANTITY Total distributed 50 mg 100 mg Schein 226,095x100s 538,822x50s Duramed 7,470x100s 11,178x50s Medicis 46,345x100s 57,107x50s Medicis 4,084x500s 4,508x500s. -4-REASON Bulk Minocycline was recalled by Roussel Corporation (parent firm of Biochimica Opos) due to AADA discrepancies regarding the manufacturing process; AADA was withdrawn. _______________ PRODUCT Doxycycline Hyclate 100 mg tablets, 50 mg capsules and 100 mg capsules labeled "Manufactured by Halsey Drug Co., Inc., Brooklyn, N.Y.", "Manufactured by: Rachelle Laboratories, Inc., Culver, Indiana", "Mfd. by: Rachelle-Houba Laboratories, Inc., Culver, Indiana, a subsidiary of Halsey Drug Co., Inc., Brooklyn, N.Y.", or "Manufactured by Rachelle Laboratories, Inc., Culver, Indiana, A Subsidiary of Halsey Drug Co., Inc., Brooklyn, NY" as follows: 1. ALIGEN Doxycycline Hyclate Tablets, USP 100 mg in bottles of 50 tablets distributed by Aligen Independent Laboratories, Inc., 2. ALIGEN Doxycycline Hyclate Tablets, USP 100 mg in bottles of 500 tablets distributed by Aligen Independent Laboratories, Inc., 3. APOTHECON Doxycycline Hyclate Tablets, USP 100 mg in bottles of 50 tablets, Manufactured for APOTHECON, A Bristol-Myers Squibb Co., 4. APOTHECON Doxycycline Hyclate Tablets, USP 100 mg in bottles of 500 tablets, Manufactured for APOTHECON, A Bristol-Myers Squibb Co., 5. APOTHECON Doxycycline Hyclate 100 mg capsules, USP in bottles of 50 capsules, APOTHECON, A Bristol-Myers Squibb Co., 6. APOTHECON Doxycycline Hyclate 100 mg capsules, USP in bottles of 500 capsules, APOTHECON, A Bristol-Myers Squibb Co., 7. Doxychel Doxycycline Hyclate Tablets USP 100 mg in bottles of 50 tablets, Rachelle Laboratories, Inc., 8. Doxychel Doxycycline Hyclate Tablets USP 100 mg in bottles of 500 tablets, Rachelle Laboratories, Inc., 9. Doxychel Doxycycline Hyclate Capsules USP 100 mg in bottles of 50 capsules, Rachelle Laboratories, Inc., 10. Geneva Doxycycline Hyclate Tablets, USP 100 mg in bottles of 50 tablets, distributed By Geneva Pharmaceuticals, Inc., 11. Geneva Doxycycline Hyclate Tablets, USP 100 mg in bottles of 500 tablets, distributed by Geneva Pharmaceuticals, Inc., -5- 12. Geneva Doxycycline Hyclate 50 mg capsules, USP in bottles of 50 capsules distributed by Geneva Pharmaceuticals, Inc., 13. Geneva Doxycycline Hyclate 100 mg capsules, USP in bottles of 50 capsules distributed by Geneva Pharmaceuticals, Inc., 14. Geneva Doxycycline Hyclate 100 mg capsules, USP in bottles of 500 capsules distributed by Geneva Pharmaceuticals, Inc., 15. HALSEY Doxycycline Hyclate Tablets, USP 100 mg in bottles of 50 tablets, Manufactured by: Rachelle [or Rachelle-Houba] Laboratories, Inc., 16. HALSEY Doxycycline Hyclate Tablets, USP 100 mg in bottles of 500 tablets, Manufactured by: Rachelle [or Rachelle-Houba] Laboratories, Inc., 17. HALSEY Doxycycline Hyclate 50 mg capsules, USP in bottles of 50 capsules, Halsey Drug Co., Inc., 18. HALSEY Doxycycline Hyclate 100 mg capsules, USP in bottles of 50 capsules, Halsey Drug Co., Inc., 19. HALSEY Doxycycline Hyclate 100 mg capsules, USP in bottles of 500 capsules, Halsey Drug Co., Inc., 20. Major Doxycycline Hyclate Tablets, USP 100 mg in bottles of 50 tablets, Manufactured for Major Pharmaceutical Corp., 21. Major Doxycycline Hyclate Tablets, USP 100 mg in bottles of 500 tablets, Manufactured for Major Pharmaceutical Corp., 22. Major Doxycycline Hyclate 50 mg capsules, USP in bottles of 50 capsules Major Pharmaceutical Corp., 23. Major Doxycycline Hyclate 100 mg capsules, USP in bottles of 50 capsules Major Pharmaceutical Corp., 24. Major Doxycycline Hyclate 100 mg capsules, USP in bottles of 500 capsules distributed by Major Pharmaceutical Corp., 25. Mason Doxycycline Hyclate 100 mg capsules, USP in bottles of 500 capsules distributed by Mason Distributors, Inc., 26. Moore Doxycycline Hyclate Tablets, USP 100 mg in bottles of 50 tablets distributed by h.l. Moore Drug Exchange, and labeled 27. Moore Doxycycline Hyclate Tablets, USP 100 mg in bottles of 500 tablets, distributed by h.l. Moore Drug Exchange, -6- 28. Moore Doxycycline Hyclate 50 mg capsules, USP in bottles of 50 capsules distributed by h.l. Moore Drug Exchange, 29. Moore Doxycycline Hyclate 100 mg capsules, USP in bottles of 50 capsules distributed by h.l. Moore Drug Exchange, 30. Moore Doxycycline Hyclate 100 mg capsules, USP in bottles of 500 capsules distributed by h.l. Moore Drug Exchange, 31. PARMED Doxycycline Hyclate 50 mg capsules, USP in bottles of 50 capsules distributed by Parmed Pharmaceuticals, Inc., 32. PARMED Doxycycline Hyclate 100 mg capsules, USP in bottles of 50 capsules distributed by Parmed Pharmaceuticals, Inc., 33. Qualitest Doxycycline Hyclate Tablets, USP 100 mg in bottles of 50 tablets, and labeled "Mfg. for: QUALITEST PRODUCTS, INC., 34. Qualitest Doxycycline Hyclate Tablets, USP 100 mg in bottles of 500 tablets, Mfg. for: QUALITEST PRODUCTS, INC., 35. Qualitest Doxycycline Hyclate 50 mg capsules, USP in bottles of 50 capsules and labeled "Mfg. for: QUALITEST PRODUCTS, INC., 36. Qualitest Doxycycline Hyclate 100 mg capsules, USP in bottles of 50 capsules QUALITEST PRODUCTS, INC., 37. Qualitest Doxycycline Hyclate 100 mg capsules, USP in bottles of 500 capsules QUALITEST PRODUCTS, INC., 38. Warner Chilcott Doxycycline Hyclate Tablets, USP 100 mg in bottles of 50 tablets, Manufactured for WARNER CHILCOTT LABS Div of Warner-Lambert Co., 39. Warner Chilcott Doxycycline Hyclate Tablets, USP 100 mg in bottles of 500 tablets, Manufactured for WARNER CHILCOTT LABS Div of Warner-Lambert Co., 40. WARNER CHILCOTT Doxycycline Hyclate 50 mg capsules, USP in bottles of 50 capsules WARNER CHILCOTT LABS, Div of Warner-Lambert Co., 41. WARNER CHILCOTT Doxycycline Hyclate 100 mg capsules, USP in bottles of 500 capsules Manufactured for: WARNER CHILCOTT LABS, Div of Warner-Lambert Co. Recall #D-141/143-7. CODE APOTHECON Lots: 4J98931, 4J98942, 4J98953, 4K98332, 5F06053, 5F07390, 5F07401, 5G06064, 5K09524, 5L09535, 5M08132, 6A18143, 6A18154, 6A19452, 6F16377, 6F16388, 6J16668, 6F16701, 6J16723, 6L16690. -7- The following lot numbers of the brands other than APOTHECON are under recall: 50 mg. capsules: These products bear seven digit lot numbers and the first three digits are 552. For lots ending in the number 5: Lots containing the numbers 02 or a larger number as the fourth and fifth digits and the letter R as the sixth digit. All codes ending in a 5 and containing the letter W. For lots ending in the number 6: All lots containing the letter A, B, C, D, E, F, G, H, K, or M. 100 mg. capsules: These products bear seven digit lot numbers and the first three digits are 553. For lots ending in the number 5: All codes containing the letter K, M, R, or W PLUS all codes with the numbers 05 or a larger number in the fourth and fifth positions and containing an H in the code. For lots ending in the number 6: All lots containing the letter A, B, C, D, E, F, G, H, or K PLUS all codes with the number/letter combination 01M or 02M. 100 mg. tablets: These products bear seven digit lot numbers and the first three digits are 581. For lots ending in the number 4: All codes containing the letter H, K, M, R, or W. For lots ending in the number 5: All codes. For lots ending in the number 6: All codes containing the letter A, B, C, D, E, F, G, H, K, or M. MANUFACTURER Houba, Inc., A Subsidiary of Halsey Drug Co., Inc., Culver, Indiana. RECALLED BY letter dated January 3, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY Approximately 150 million capsules were distributed. REASON ANDA discrepancies and lack of assurance of stability. _______________ PRODUCT Lederle brand Cefaclor Capsules, USP, 250 mg and 500 mg, Rx antibiotic. Recall #D-146/147-7. CODE All lots within expiration date. MANUFACTURER Lederle Laboratories, Pearl River, New York. -8-RECALLED BY Wyeth-Ayerst Laboratories, St. Davids, Pennsylvania, by letter dated February 19, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 692,229 bottles were distributed. REASON Bulk Cefaclor was recalled b Roussel Corp. (parent firm of Biochimica Opos) due to AADA discrepancies regarding the manufacturing process; AADA was withdrawn. _______________ PRODUCT Lederle brand Cefaclor for Oral Suspension, USP, 125 mg/5 ml, 187 mg/5 ml, 250 mg/5 ml, and 375 mg/5 ml, Rx antibiotic. Recall #D-148/151-7. CODE All lots within expiration date. MANUFACTURER Lederle Laboratories, Pearl River, New York. RECALLED BY Wyeth-Ayerst Laboratories, St. Davids, Pennsylvania, by letter dated February 19, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 1,433,816 bottles were distributed. REASON Bulk Cefaclor was recalled by Roussel Corporation (parent firm of Biochimica Opos) due to AADA discrepancies regarding the manufacturing process; AADA was withdrawn. _______________ PRODUCT Lederle brand Clindamycin Phosphate Injection, a prescription drug given intramuscularly or intravenously for the treatment of serious infections caused by susceptible anaerobic bacteria: (a) 2 ml; (b) 4 ml; (c) 6 ml; (d) 60 ml vials. Recall #D-152/155-7. CODE Lot numbers: (a) 409 835 (EXP 2/97), 409 836 (EXP 2/97), 411 803 (EXP 5/97), 417 827 (EXP 6/97); (b) 409 837 (EXP 2/97), 409 838 (EXP 2/97), 411 804 (EXP 2/97), 413 817 (EXP 6/97), 413 818 (EXP 6/97), 417 828 (EXP 6/97), 417 829 (EXP 6/97), 417 830 (EXP 7/97) (c) 409 834 (EXP 2/97), 411 801 (EXP 2/97) 411 802 (EXP 6/97), 413 816 (EXP 6/97) 417 825 (EXP 6/97), 417 826 (EXP 7/97) 418 267 (EXP 7/97), (d) 387 801 (EXP 2/97), 411 800 (EXP 7/97) 413 815 (EXP 7/97). MANUFACTURER Lederle Parenterals, Inc., Carolina, Puerto Rico. RECALLED BY Wyeth Ayerst Laboratories, St. Davids, Pennsylvania, by letter dated February 19, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 300,389 vials were distributed. -9-REASON Bulk Clindamycin was recalled by Roussel Corporation (parent firm of Biochimica Opos) due to AADA discrepancies regarding the manufacturing process; AADA was withdrawn. RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III ========== _______________ PRODUCT Gastrografin (Diatrizoate Meglumine 660 mg/ml and Diatrizoate Sodium, 100 mg/ml Solution, USP), Oral/Rectal Solution in 120 ml bottles a prescription iodinated radiopaque contrast medium. Recall #D-144-7. CODE Lot #ML015 EXP 11/00. MANUFACTURER Bristol-Myers Squibb Company, Bristol-Myers Squibb U.S. Pharmaceutical and Mead Johnson Nutritional Group, Evansville, Indiana. RECALLED BY Bracco Diagnostics, Inc., Princeton, New Jersey, by letter on February 18, 1997. Firm- initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 36,012 4-ounce bottles in 3,001 cases of 12 bottles each. REASON Presence of foreign substance (small rubber particles from filling machine seal found in several units). _______________ PRODUCT Transderm-Nitro (Transdermal Nitroglycerin) 100 mg (0.8 mg/hour), Rx, institutional use only, indicated for the prevention of angina pectoris. Recall #D-145-7. CODE Lot #C9080 EXP 8/97. MANUFACTURER Reservoir: Ciba Pharmaceuticals Division (Old Name at time of Manufacturing) Ciba-Geigy Corporation, Summit, New Jersey; System Fabrication: Ivers-Lee (now Sharp/Ivers-Lee) West Caldwell, New Jersey. RECALLED BY Novartis (formerly Ciba) Pharmaceuticals Corporation, Summit, New Jersey, by letter February 20, 1997, followed by telephone. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 774 cartons (30 systems per carton) were distributed. REASON Product lacks stability (failed content assay after two years-- Spec is 85-ll0mg/system, found as low as 80%) -10-RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II ======= _______________ PRODUCT Source Plasma. Recall #B-558-7. CODE Unit numbers: EUP416, EUP431, EUP444, EUP458, EUP472, EUP497, HVM413, HVM426, HVM438, HVM461, HVM472, HVM522, HVM577, HVM616, HVM631, HVM644, HVM674, HVM687, HVM702, HVM732, HVM744, HVM757, HVM766, HVN070, HVN084, HVN092, HVN105, HVN118, HVN128, HVN138, HVN149, HVN175, HVN191, HVN204, HVN217. MANUFACTURER Plasma Services of Montana, Billings, Montana. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by letter dated April 17, 1994. Firm-initiated recall complete. DISTRIBUTION Pennsylvania. QUANTITY 35 units were distributed. REASON Blood products tested negative for the antibody to the human immunodeficiency virus type 1 (anti-HIV-1), but were collected from a donor who previously tested Western blot indeterminate. _______________ PRODUCT Source Plasma. Recall #B-559-7. CODE Unit numbers: EUP284, EUP297, EUP313, EUP328, EUP348, EUP359, EUP370, EUP383, EUP395, EUP406, EUP419, EUP446, EUP460, EUP474, EUP484, EUP499, HVM415, HVM427, HVM440, HVM352, HVM462, HVM473, HVM482, HVM494, HVM511, HVM524, HVM579, HVM594, HVM618, HVM633, HVM646, HVM657, HVM676, HVM689, HVM704, HVM711, HVM720, HVM734, HVM746, HVM755, HVM768, HVM783, HVM794, HVM809, HVM822, HVM835, HVM852, HVM908, HVM919, HVM934, HVM946, HVM962, HVM976, HVM991, HVN007, HVN030, HVN059, HVN072, HVN086, HVN094, HVN107, HVN120, HVN130, HVN140, HVN151, HVN165, HVN177, HVN193, HVN206, HVN219, HVN232. MANUFACTURER Plasma Services of Montana, Billings, Montana. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by letter dated April 19, 1994. Firm-initiated recall complete. DISTRIBUTION Pennsylvania. QUANTITY 71 units were distributed. REASON Blood products tested negative for the antibody to the human immunodeficiency virus type 1 (anti-HIV-1), but were collected from a donor who previously tested Western blot indeterminate. -11-_______________ PRODUCT (a) Red Blood Cells; (b) Fresh Frozen Plasma. Recall #B-567/568-7. CODE Unit #5721198. MANUFACTURER Oklahoma Blood Institute, Oklahoma City, Oklahoma. RECALLED BY Manufacturer, by fax and telephone on November 28 and 29, 1995. Firm-initiated recall complete. Distribution Massachusetts and New York. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor who reported a diagnosis of cancer. _______________ PRODUCT Red Blood Cells. Recall #B-570-7. CODE Unit #38FE17220. MANUFACTURER American Red Cross Blood Services, Fort Wayne, Indiana. RECALLED BY Manufacturer, by telephone on October 8, 1996. Firm-initiated recall complete. DISTRIBUTION Indiana. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who reported travel to an area considered endemic for malaria. _______________ PRODUCT (a) Red Blood Cells; (b) Platelets; รพ Recovered Plasma. Recall #B-575/577-7. CODE Unit #13FN05688. MANUFACTURER American Red Cross Blood Services, Detroit, Michigan. RECALLED BY Manufacturer, by letter dated October 16, 1996. Firm-initiated recall complete. DISTRIBUTION Michigan. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor taking the drug Proscar. _______________ PRODUCT Blood Storage Freezers, 20 cubic feet chest units and 13 cubic feet upright unit. Recall #B-592-7. Code Brand Model Number Serial Number Baxter RC2090A12 3l5l82 Baxter RCUl386Al4 3l8792 Jewett LTUR-13V14 314749 Revco UFRC1386-5-A12 316149 Revco UFRC1386-7-A14 320399. MANUFACTURER Revco Lindberg, Ashville, North Carolina. -12-RECALLED BY Manufacturer, by telephone followed by fax the week of March 3, 1997. Firm-initiated recall ongoing. DISTRIBUTION Arizona, California, Iowa, Chile, Honduras. QUANTITY 5 units were distributed. REASON Blood storage freezers have failing/defective compressors. RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ======= _______________ PRODUCT Red Blood Cells. Recall #B-551-7. CODE Unit numbers: 12FQ39762, 12FQ39735, 12LF47760, 12LF47758, 12LE46283, 12LE46280, 12LW21408, 12LW21409, 12FN21077, 12FN21075, 12FN21028, 12FN21074, 12FN21099, 12FN21088, 12FN21085, 12FN21092. MANUFACTURER American Red Cross Blood Services, Charlotte, North Carolina. RECALLED BY Manufacturer, by telephone on December 30 and 31, 1996, January 1 and 30, 1997. Firm- initiated recall complete. DISTRIBUTION North Carolina. QUANTITY 16 units were distributed. REASON Blood products may have been exposed to unacceptable shipping temperatures. _______________ PRODUCT Platelets, Pheresis. Recall #B-557-7. CODE Unit numbers 10000468 and 10000470. MANUFACTURER W.E. and Lela I. Stewart Blood Center, Inc., Tyler, Texas. RECALLED BY Manufacturer, by letter dated January 17 or 28, 1997. Firm-initiated recall complete. DISTRIBUTION Texas. QUANTITY 2 units were distributed. REASON Blood products were incorrectly tested for the antibody to the human immunodeficiency virus types 1 and 2 (anti-HIV-1/2). _______________ PRODUCT Abbott HIVAG-1 Monoclonal EIA Kit, Antibody to Human Immunodeficiency Virus Type 1 (HIV-1). Recall #B-563-7. CODE Masterlots to be destroyed: 20387M401, 20388M401, 21204M201, 21205M201, 21259M101, 21260M101, 21375M401, 21376M401, 21453M301, 21454M301, 21456M301, 21673M201, 21674M201, 22043M201, 22182M401, 22371M101, 22383M301, 22384M301, 23087M401, 23088M401, 23286M401, 23287M401, 23812M101, 24035M201, 24560M401, 25006M401, 25491M101 -13- Masterlots to be relabeled with new expiration dates: 22181M401 25345M301 23705M201 25347M301 23821M101 25770M201 24077M401 25778M201 24476M301 25780M201 24495M201 26268M101 24529M201 26425M101 24681M301 26706M201. MANUFACTURER Abbott Laboratories, Diagnostic Division, Abbott Park, Illinois. RECALLED BY Manufacturer, by letter on March 31, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY 5,632 - 100 test kits and 7,813 - 1000 test kits were distributed. REASON HIVAG-1 Monoclonal masterlots does not consistently meet the Positive Control validity requirement through the currently labeled expiration dating. _______________ PRODUCT Red Blood Cells. Recall #B-569-7. CODE Unit #23132-1171. MANUFACTURER United Blood Services, Billings, Montana. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by letter dated October 9, 1996. Firm-initiated recall complete. DISTRIBUTION Montana. QUANTITY 1 unit was distributed. REASON Blood product remained at room temperature for more than 30 minutes. _______________ PRODUCT Red Blood Cells. Recall #B-578-7. CODE Unit numbers: 12419-2389, 12418-7597, 12418- 7596, 12418-7595, 12418-7594, 12418-7593, 12418-7592, 12418-7591, 12418-7590, 12418-7589, 12418-7588. MANUFACTURER United Blood Services, Albuquerque, New Mexico. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by telephone on September 11, 1996. Firm- initiated recall complete. DISTRIBUTION New Mexico. QUANTITY 11 units were distributed. REASON Blood products were prepared from units of whole blood that were exposed to temperatures exceeding 10 degrees C. RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II ========= _______________ PRODUCT Baxter InterLink System T-Connector Extension Sets with Luer Slip Adapters, (a) Catalog No. 2N3326, InterLinkR System T-Connector Extension Set -14- (b) Catalog No. 2N3329, InterLinkR System T-Connector Extension Set (c) Catalog No. 2N3330, InterLinkR System Dual Line T-Connector Extension Set (d) Catalog No. 2N3332, InterLinkR System T-Connector Extension Set, 0.22 Micron Filter (e) Catalog No. 3C0007, InterLinkR System Continu-Flo Solution Set, 3-Way Stopcock, T-Connector Extension Set (f) Catalog No. 3C0026, InterLinkR System BuretrolR Solution Set, Extension Set, 3-Way Stopcock, T-Connector Extension Set (g) Catalog No. 3C0028, InterLinkR System Continu-FloR Solution Set, 3-Way Stopcock, T-Connector Extension Set (h) Catalog No. 3C0047, InterLinkR System 4-Way Large Bore Stopcock Extension Set, T-Connector Extension Set (i) Catalog No. 3C0050, InterLinkR System Continu-FloR Set, Three 4-Way Stopcocks Extension Set, T-Connector Extension Set (j) Catalog No. 1C8567, InterLinkR System Extension Set, T-Connector Set (k) Catalog No. 1C8571, InterLinkR System Extension Set, T-Connector. Recall #Z-408/418-7. CODE All lots. MANUFACTURER Baxter Healthcare Corporation, Aibonito, Puerto Rico and Cleveland, Mississippi. RECALLED BY Baxter Healthcare Corporation, Round Lake, Illinois, by letter dated March 14, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY 4,990,004 sets were distributed; firm estimated that 5 percent remained on market at time of recall initiation. REASON The luer slip adapter of the InterLinkR T-Connector Extension Set may inadvertently disconnect from mated connections. _______________ PRODUCT Chocolate II Agar Plates, for in-vitro diagnostic use, Catalog Nos. 4321169 & 4321267. Recall #Z-423-7. CODE Lot Nos. A3RTWG, A3RTWZ, A3RTXJ, A3RTXNK, A3RTYB, A4RTZZ, A4RUAA, A4RUAN, A4RUAR, A4RUBN, A4RUGF, BIRUGU, BIRUGU, BIRUHJ, B2RUJZ, B2RUKR, B2RULM, B2RULL, B2RUMF, B3RUMI, B3RUNB, B3RUNX, B3RUOL, B3RUPA, B3RUPO, B3RUPB, B3RUPX, B3RUPP, B3RUPZ, B4RUST, B4RUTM, B4RUUA, B4RUWA, C2RUYW, C2RUZS, C3RWBI, C3RWCH, C3RWCZ, C3RWGN, -15- C4RWHB, C4RWHX, C4RWIR, C4MWJF, C4RWJG, C4RWIZ, C4RWJU, C5RWKK, C5RWLC, C5MWNH, C5RWLX, C5RWMI, C5RWMJ. MANUFACTURER Becton Dickinson Microbiology Systems, Cockeysville, Maryland. RECALLED BY Manufacturer, by letter dated January 21, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY 4,026,980 units were distributed. REASON There was decreased growth of QC organism Haemophilus Influenzae. _______________ PRODUCT Abbott IMx & AxSYM PSA (Prostate Specific Antigen) Reagent Packs, for in-vitro diagnostic use: (a) IMx Kit, Catalog No. 2245-20, (b) AxSYM Kit, Catalog No. 7A49-20. Recall #Z-424/425-7. CODE Lot Numbers: (a) 25102Q100, 25104Q100, 25107Q100, 26646Q100, 23569Q100, 25103Q100 (b) 23523Q100, 23523Q101, 23535Q100, 23535Q101, 23547Q100, 24236Q100, 24236Q101, 24239Q100, 25245Q100, 25246Q100, 25293Q100, 25414Q100, 25415Q100, 25440Q100, 25441Q100, 25441Q101, 25442Q100, 25442Q101, 25443Q100, 25443Q101. MANUFACTURER Abbott Health Products, Inc., Barceloneta, Puerto Rico. RECALLED BY Abbott Laboratories, Diagnostic Division, Abbott Park, Illinois, by telephone on March 20, 1997, followed by letter. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY (a) 14,244 packs; (b) 28,138 packs were distributed; firm estimated that 50 percent of product remained on market at time of recall initiation. REASON The kits give falsely elevated PSA values with samples from patients who have undergone radical prostatectomies. RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ======== _______________ PRODUCT Simon Nitinol Filter Set, indicated for use in the prevention of recurrent pulmonary embolism via placement in the vena cava via a jugular/femoral approach. Recall #Z-426-7. CODE Catalog #2220J, Lot #509126D. MANUFACTURER Nitinol Medical Technologies, Inc., Boston, Massachusetts. -16-RECALLED BY Manufacturer, by letter of March 5, 1997. Firm-initiated recall ongoing. DISTRIBUTION Alabama, New Jersey, Ohio, Pennsylvania. QUANTITY 7 units were distributed. REASON The outer box label indicated catalog no. 2120F (Femoral), which is incorrect while the inner pouch was labeled 2220J (Jugular) which is correct. RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS II =========== _______________ PRODUCT Nutrena Super 20 Dairy Pellets (non-medicated). Recall #V-035-7. CODE None. MANUFACTURER Cargill Nutrena Feed, Wilson, North Carolina. RECALLED BY Cargill Animal Nutrition Division, Wayzata, Minnesota, by telephone on February 10, 1997. Firm-initiated recall complete. DISTRIBUTION North Carolina. QUANTITY 46,830 pounds were distributed. REASON The Nutrena Super 20 Dairy Pellets (non-medicated) were loaded onto a truck containing a swine feed medicated with chlortetracycline, sulfamethazine and penicillin (ASP) and delivered to two dairies as a non-medicated feed. -17- END OF ENFORCEMENT REPORT FOR April 16, 1997. BLANK PAGES MAY FOLLOW. ####End of Enforcement Report for