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FDA Recalls & Court Actions: May 9 & 16, 1990

Executive Summary

CLASS II -- FUROSEMIDE 12.5 MG VETERINARY TABLETS In bottles of 100, 500 or 1,000 tablet, an Rx diuretic under the following labels: Vedco, The Butler Company, Bolar Pharmaceutical, IDE -- Interstate, Burns Veterinary Supply (100s); Vedco, IDE -- Interstate, Burns Veterinary Supply, The Butler Company, H.L. Moore Drug Exchange, Bolar Pharmaceutical (500s); Bolar Pharmaceutical (1,000s). Lot numbers: 014459, 023879, 023884, 036894, 037620, 039010, 043965, 048418, 074705, 076147, 077898, 084708, 085452, 103301, 103312, 108709, 116383, 124999, 127146. Manufacturer: Bolar Pharmaceutical Company, Inc., Copiague, New York. Recalled by: Manufacturer, by letter Feb. 19-20, 1990. Firm-initiated recall ongoing. Distribution: Pennsylvania, Wisconsin, Massachusetts, Georgia, Ohio, North Carolina, New York, Florida, New Jersey. 25,633 bottles of 100, 60,496 bottles of 500 and 33 bottles of 1,000 were distributed. Reason: Product lacks assurance that they were manufactured in conformity with conditions approved in the Abbreviated New Drug Application. CLASS II -- HYPERSTAT I.V. INJECTION, USP (DIAZOXIDE) 300 mg/20 ml ampul, an Rx drug for short-term use in the emergency reduction of blood pressure in severe, nonmalignant and malignant hypertension in hospitalized adults. Lot numbers: 8-APJ-1002 EXP 4/91, 8-APJ-1003 EXP 6/91, 8-APJ-1004 EXP 7/91, 8-APJ-1005 EXP 8/91, 8-APJ-1006 EXP 8/91. Manufacturer: Schering Corporation, Manati, Puerto Rico. Recalled by: Schering Labs, Union, New Jersey, by letter March 8, 1990. Firm-initiated recall ongoing. Distribution: Nationwide, Puerto Rico. 8,560 ampuls (8-APJ-1002), 9,394 ampuls (8-APJ-1003), 8,874 ampuls (8-APJ-1004), 7,288 ampuls (8-APJ-1005), 8,352 ampuls (8-APJ-1006) were distributed. Reason: Product does not meet pH specifications which may cause crystallization. CLASS II -- NITROUS OXIDE USP LIQUID AND GAS In the following size cylinders: E -- 1,560 liters, F -- 4,840 liters, G -- 13,515 liters, H -- 15,490 liters, VGL -- 375 pounds, R -- 5 pounds. All nitrous oxide filled and shipped between March 21, 1990 and April 5, 1990. Manufacturer: Puritan Bennett Corporation, Indianapolis, Indiana (repacker). Recalled by: Manufacturer, by telephone April 5, 1990 followed by letter. Firm-initiated recall ongoing. Distribution: Indiana. Undetermined quantity. Reason: A cylinder was found adulterated with 15% carbon dioxide. CLASS II - (a) PLATELETS; (b) POOLED RECOVERED PLASMA (a) Unit number 8055717; (b) Pool number 89-12292 (which includes Recovered Plasma, unit 8073362). Manufacturer: The Blood Center for Southeast Louisiana, New Orleans, Louisiana. Recalled by: Manufacturer, (a) by telephone June 26, 1989; (b) by telephone Sept. 27, 1989. Firm-initiated recall complete. Distribution: (a) Louisiana; (b) California. One unit of each component was distributed and destroyed. Reason: Blood products testing repeatably reactive for the antibody to the human immunodeficiency virus by EIA (anti-HIV-1) and the antibody to the human T-lymphotropic virus by EIA (anti-HTLV-1) were distributed. CLASS II -- TESULOID KIT For the preparation of Technetium Tc 99m Sulfur Colloid, an Rx product used for radioactive imageing. Lot number 9G06807. Manufacturer: Bristol-Myers Squibb Company, New Brunswick, New Jersey. Recalled by: Manufacturer, by letter March 8-9, 1990. Firm-initiated recall ongoing. Distribution: Nationwide. 1,325 units were distributed. Reason: Kit components include a syringe of sterile .25N hydrochloric acid which is mislabeled as the buffer solution component. CLASS III -- AMINOPHYLLINE TABLETS (a) 100 mg; (b) 200 mg, in 100, 1,000 tablet bottles and in 100 tablet unit dose packages, an Rx product used as a bronchodilator, under the Rugby, West-Ward, Schein, and Moore labels. Lot numbers: (a) 50254 EXP 4/91, 50560 EXP 8/91, 50561 EXP 8/91, 50561 B EXP 8/91, 50561 C EXP 8/91, 50561 D EXP 8/91; (b) 50271 A EXP 7/91, 50271 EXP 3/91, 50286 EXP 3/91, 50286 EXP 3/91. Manufacturer: West-Ward Pharmaceutical Corporation, Eatontown, New Jersey. Recalled by: Manufacturer, by telephone March 5, 1990 followed by letter March 9, 1990. Firm-initiated recall ongoing. Distribution: Nationwide. (a) 2,407 bottles of 1,000, 2,546 bottles of 100 and 144 unit dose packages; (b) 420 bottles of 1,000 and 1,360 bottles of 100 were distributed. Reason: Subpotency of the ethylenediamine component. CLASS III -- CONJUGATED ESTROGENS TABLETS USP In 100 and 1,000 tablet bottles, an Rx drug used primarily for moderate to severe vasomotor symptoms associated with menopause, under the Zenith, Interstate Drug Exchange, Best Generics, Major Pharmaceutical labels. (a) 0.3 mg; (b) 0.625 mg; (c) 1.25 mg. Lot numbers: 3636-18 EXP 3/90, 2042-213 EXP 3/90, 2042-216 EXP 4/90, 2042-218 EXP 5/90, 2045-242 EXP 3/90, 2045-243 EXP 3/90, 2045-245 EXP 4/90, 2045-247 EXP 6/90. Manufacturer: Zenith Laboratories, Inc., Northvale, New Jersey. Recalled by: Manufacturer, by telephone March 13, 1990 followed by letters March 9-10, 1990. Firm-initiated recall ongoing. Distribution: Nationwide. 51,849 (100 tablet bottles), 15,166 (1,000 tablet bottles) were distributed; firm estimates very little or no product remains on market. Reason: Products fail content uniformity requirements. CLASS III -- CONRAY 325 STERILE SOLUTION In 50 ml vials, distributed individually and as part of the Conray Angio-Pak (Angiourography Administration Kit) which contains 2/50 ml vials of Conray 325. Lot numbers: D151A EXP 10/92, D151A1 EXP 10/92. Manufacturer: Mallinckrodt Parenterals, Raleigh, North Carolina. Recalled by: Mallinckrodt Medical, Inc., St. Louis, Missouri, by telephone April 9, 1990 and by letter April 12, 1990. Firm-initiated recall ongoing. Distribution: Nationwide. 13,500 vials and 24 kits were distributed. Reason: Label incorrectly declares chemical name as iothalamate meglumine instead of iothalmate sodium. Usage section of label has correct declaration. CLASS III --H.L. MOORE BRAND VALPROIC ACID 250 mg Soft Gel Capsules, in 100 capsule bottles, an Rx anti-convulsant. Lot numbers: 149209 EXP 11/91, 990198 EXP 1/92. Manufacturer: Chase Chemical Company, Newark, New Jersey. Recalled by: Manufacturer, by telephone March 22, 1990 followed by letter March 23, 1990. Firm-initiated recall ongoing. Distribution: Connecticut. 884 bottles of lot number 149209, 1,488 bottles of lot number 990198 were distributed. Reason: Label does not state name and address of manufacturer or address of distributor. CLASS III -- EXTENSION NOTICE EXTENSION NOTICE: Insulin and Sodium Chloride Injection, USP, in 50 ml vials. Recall #D-175-0, which appeared in the March 28, 1990 "Enforcement Report" has been extended to include lot number 78807 EXP 7/90. CLASS III -- LEDERLE BRAND NYSTATIN POWDER, USP For extemporaneous preparation of oral suspension, in 150 million unit package, an Rx drug. Lot numbers: 253-471 EXP 4/91, 250-346 EXP 3/91. Manufacturer: Lederle Laboratories Division, Pearl River, New York. Recalled by: Manufacturer, by telephone April 9, 1990 and by letter April 23, 1990. Firm-initiated recall ongoing. Distribution: Illinois, Texas, California, Pennsylvania. 3,990 units were distributed. Reason: Product does not meet loss on drying specifications. CLASS III -- Rx SMALL VOLUME PARENTERALS (SOLUTION) Various strengths and fill sizes under the Quad label: (a) Nitroglycerin Injection, USP, 10 mg/ml in 5 cc and 10 cc vials; (b) Metoclopramide HCl Injection (non-USP version), 5 mg/ml, 2 cc vials; (c) Metoclopramide HCl Injection, USP, 5 mg/ml, in 2 cc vials. Lot numbers: (a) 5 cc -- 609H30 7/90, 609J19 5/91; 10 cc -- 609J06 2/91; (b) 2 cc -- 235H34 8/90, 235H35 8/90, 235H44 11/90, 235H49A 12/90, 235H49B 12/90, 235H49C 12/90, 235H49D 12/90, 235J09 3/91, 235J10A 3/91, 235J10B 3/91; (c) 235J10C 3/91, 235J16A 4/91, 235J16B 4/91, 235J16C 4/91, 235J16D 4/91, 235J18 5/91, 235J25A 6/91, 235J26 6/91, 235J30 7/91, 235J34 8/91, 235J42 10/91. Manufacturer: Quad Pharmaceuticals, Inc., Indianapolis, Indiana. Recalled by: Manufacturer, by letter April 23, 1990. Firm-initiated recall ongoing. Distribution: Nationwide. (a) 45,170 vials; (b) 1,247,575 vials; (c) 1,397,225 vials were distributed. Reason: Unapproved overages in active ingredients and/or preservatives. CLASS III -- SOMOPHYLLIN-CRT (TIMED-RELEASE) CAPSULES 250 mg, in bottles of 100, an Rx drug used for bronchial asthma. Lot number M0292 EXP 11/91. Manufacturer: D.M. Graham Laboratories, Inc., Hobart, New York. Recalled by: Fisons Corporation, Rochester, New York, by visit beginning on or about April 16, 1990. Firm-initiated field correction ongoing. Distribution: California, Georgia, New York. Firm estimates none remains on market. Reason: Some shipping cartons were found which declared a strength of 300 mg. The individual bottles were properly labeled. CLASS III -- THYROID TABLETS, USP (a) 1/4 grain strength; (b) 4 grain. Lot numbers: (a) W409 (uncoated), W409-1 (coated); (b) T842 (uncoated), T842-1 (coated). Manufacturer: JMI-Canton Pharmaceuticals, Canton, Ohio. Recalled by: Manufacturer, by FAX April 10, 1990 and by letter April 12, 1990. Firm-initiated recall ongoing. Distribution: Missouri, Texas. 419 bottles containing 1,008 tablets each and 251,188 bulk tablets were distributed. Reason: The 1/4 grain product was found subpotent. The 4 grain product was found superpotent. CLASS III -- VARIOUS Rx DRUGS Small volume parenterals, of various strengths and sizes per product: (1) Aminocaproic Acid Injection, USP, 250 mg/ml, 20 cc, 250 mg/ml, 96 cc, under DuPont & Quad labels; (2) Dexamethasone Sodium Phosphate Injection, USP 4 mg/ml in 5 cc vials and 4 mg/ml in 30 cc vials, under the Quad label; (3) Dexamethasone Sodium Phosphate Injection, USP, 10 mg/ml, in 10 cc vials, under the Quad label; (4) Dexamethasone Sodium Phosphate Injection, USP, 20 mg/ml, in 5 cc vials, under the Quad label; (5) Dexamethasone Sodium Phosphate Injection, USP, 24 mg/ml, in 5 cc vials, under the Quad label; (6) Estradiol Cypionate Injection, USP, 5 mg/ml, in 10 cc vials, under the Rugby label; (7) Fluphenazine Decanoate Injection, 25 mg/ml, in 5 cc vials, under the Quad, DuPont and Rugby labels; (8) Glycopyrrolate Injection, USP, 0.2 mg/ml, in 1 cc, 2 cc, 5 cc and 20 cc vials, under the Quad label; (9) Haloperidol Injection, USP, 5 mg/ml, in 1 and 10 cc vials, under the DuPont and Quad labels; (10) Hydrocortisone Sodium Phosphate Injection, USP, 50 mg/ml, in 2 cc and 10 cc vials, under the Quad label; (11) Methotrexate Sodium Injection, USP, 25 mg/ml, in 2 cc, 4 cc, and 8 cc vials, under the Quad label; (12) Methyldopate Hydrochloride Injection, USP, 50 mg/ml, in 5 cc and 10 cc vials, under the Quad label; (13) Nalbuphine Hydrochloride Injection, 10 mg/ml, in 1 cc vials under the DuPont and Quad labels, and in 10 cc vials, under the Bioline, DuPont, Goldline, Quad, Rugby, and Schein labels; (14) Nalbuphine Hydrochloride Injection, 20 mg/ml, in 1 cc vials, under the DuPont and Quad labels; and in 10 cc vials under the Quad, Rugby and Schein labels; (15) Naloxone Hydrochloride Injection, USP, 0.4 mg/ml, in 1 cc and 10 cc vials, under the Quad label; (16) Naloxone Hydrochloride Injection, USP, 0.02 mg/ml, in 2 cc vials, under the Quad label; (17) Naloxone Hydrochloride Injection, USP, 1 mg/ml, in 2 cc vials, under the Quad label; (18) Procainamide Hydrochloride Injection, USP, 100 mg/ml, in 10 cc vials, under the DuPont and Quad labels; (19) Procainamide Hydrochloride Injection, USP, 500 mg/ml, in 2 cc vials, under the DuPont and Quad labels; (20) Ritodrine Hydrochloride Injection, USP, 10 mg/ml, in 5 cc vials, under the DuPont and Quad labels; (21) Ritodrine Hydrochloride Injection, USP, 15 mg/ml, in 10 cc, under the DuPont and Quad labels; (22) Vincristine Sulfate Injection, USP, in 1 mg/ml, 5 cc vials, under the Quad label. Lot numbers: (1) 20 cc -- 901H27 EXP 7/90, 901H41A EXP 10/90, 901J03 EXP 1/91, 901J10 EXP 3/91, 901J32 EXP 8/91; 96 cc -- 901H19 EXP 5/90, 90141B EXP 10/90, 901H52 EXP 12/90, 901J17 EXP 4/91, 901J31 EXP 8/91; (2) 5 cc -- 405H51 EXP 6/90, 405J14 EXP 10/90, 405J32 EXP 2/91; 30 cc -- 405H43 EXP 4/90, 405J09 EXP 8/90, 405J29 EXP 1/91; (3) 10 cc -- 406H50 EXP 6/90, 406J31 EXP 2/91; (4) 5 cc -- 407H43 EXP 4/90, 407J41 EXP 4/91; (5) 5 cc -- 408H46 EXP 5/90, 408J35 EXP 2/91; (6) 10 cc -- 417J12 EXP 9/90; (7) 5 cc -- 907H24 EXP 6/90, 907H36 EXP 9/90, 907H44 EXP 10/90, 907J03 EXP 1/91, 907J08 EXP 2/91, 907J20 EXP 11/90; (8) 1 cc -- 506H47 EXP 5/90, 506J07 EXP 8/90, 506J15 EXP 10/90, 506J26A EXP 12/90; 2 cc -- 506H40 EXP 4/90; 5 cc -- 506H42 EXP 4/90, 506J08 EXP 8/90; 20 cc -- 506H52 EXP 6/90; (9) 1 cc -- 513H40A EXP 4/90, 513H47 EXP 5/90, 513J04A EXP 7/90, 513J04B EXP 7/90, 513J15A EXP 10/90, 513J15B EXP 10/90; 10 cc -- 513H40B EXP 4/90, 513J12 EXP 9/90, 513J21 EXP 11/90; (10) 2 cc -- 442J11 EXP 9/90; 2 cc, 10 cc -- 442H41 EXP 4/90, 442J14 EXP 10/90; (11) 2 cc -- 206H50 EXP 12/90, 206J33 EXP 8/91; 4 cc -- 206J07A EXP 8/90; 8 cc -- 206J07B EXP 8/90; (12) 5 cc -- 610H44A EXP 5/90, 610J23 EXP 12/90, 610J45 EXP 5/91; 10 cc -- 610H44B EXP 5/90, 610J50 EXP 6/91; (13) 1 cc -- 504H22 EXP 6/90, 504H29 EXP 7/90, 504H37A EXP 9/90, 504H45 EXP 11/90, 504H50 EXP 12/90, 504J10 EXP 3/91, 504J19 EXP 5/91, 504J45 EXP 11/91; 10 cc -- 504H15 EXP 4/90, 504H34 EXP 8/90, 504H37B EXP 9/90, 504H52 EXP 12/90, 504J40 EXP 10/91; (14) 1 cc -- 505H50 EXP 6/90, 505K01 EXP 7/91; 10 cc -- 505H52 EXP 6/90, 505J36 EXP 3/91; (15) 1 cc -- 501J15 EXP 10/90; 10 cc -- 501J17 EXP 10/90; (16) 2 cc -- 502J22 EXP 12/90, 502J44 EXP 5/91; (17) 2 cc -- 503J10 EXP 9/90; (18) 10 cc -- 904H44 EXP 11/90, 904J01 EXP 1/91, 904J12 EXP 3/91, 904J26 EXP 6/91; (19) 2 cc -- 905H49 EXP 12/90, 905J11 EXP 3/91, 905J26 EXP 6/91; (20) 5 cc -- 902J08 EXP 8/90, 902J46 EXP 5/91; (21) 10 cc -- 903J12 EXP 9/90, 903J22 EXP 11/90; (22) 5 cc -- 200H40 EXP 4/90, 200J08 EXP 8/90. Manufacturer: Quad Pharmaceuticals, Inc., Indianapolis, Indiana. Recalled by: Manufacturer, by letter April 2-3, 1990. Firm-initiated recall ongoing. Distribution: Nationwide. 5,080,479 units were distributed. Reason: Unapproved overages in active ingredients and/or preservatives. CLASS III -- WEST-WARD BRAND DOCUSATE CALCIUM CAPSULES 240 mg in boxes of 100, an OTC stool softener. Lot number 50114 EXP 3/91. Manufacturer: West-Ward Pharmaceutical Corporation, Eatontown, New Jersey. Recalled by: Manufacturer, by telephone on or about March 2, 1990 followed by letter March 14, 1990. Firm-initiated recall ongoing. Distribution: Nationwide. 638 boxes were distributed. Reason: Label error -- One of every 20 unit dose labels declares docusate sodium instead of docusate calcium.
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