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FDA RECALLS & COURT ACTIONS: July 2, 1992

Executive Summary

CLASS I -- METAPROTERENOL SULFATE INHALATION SOLUTION, USP 5%, SULFITE-FREE A Rx oral inhalation bronchodilator for treatment of bronchial asthma; in 1 fluid ounce (30 ml) vial, for use with a hand-bulb nebulizer or IPPB apparatus, packaged under the following labels: PBI, Goldline, H.L. Moore, Qualitest, Rugby, Dey. Recall number: D-397-2. Code: All unexpired lots (13 lots). Manufacturer: Pharmaceutical Basics, Inc. (PBI), Morton Grove, Illinois. Recalled by: Manufacturer, by letter May 27, 1992 and June 1, 1992. Firm-initiated recall ongoing. Distribution: Nationwide. 100,781 units were distributed; firm estimates 20,000 units remain on the market. Reason: Microbial growth, Pseudomonas gladioli/cepacia. CLASS II -- PRO-BANTHINE TABLETS Propantheline bromide USP, 7.5 mg tablets and 15 mg tablets, a Rx oral tablet used as adjunctive therapy in the treatment of peptic ulcer, packaged as follows: (a) 7.5 mg in 100 tablet bottles; (b) 15 mg in 100 tablet unit dose boxes. Recall number: D-399/400-2. Lot numbers: (a) 0990-418 and 0990-419 EXP 9/92; (b) 0590-483 and 0590-485 EXP 5/93. Manufacturer: Searle & Company, Inc., Caguas, Puerto Rico. Recalled by: Schiapparelli Searle, a joint venture of Searle Pharmaceuticals, Inc., Skokie, Illinois, by letter dated June 19, 1992. Firm-initiated recall ongoing. Distribution: Nationwide. 16,510 bottles and 1,383 unit dose cartons were distributed. Reason: Subpotency. CLASS II -- VARIOUS Rx INJECTABLE DRUG PRODUCTS (a) Gentamicin Sulfate Injection, USP (Pediatric), 10 mg/ml, in 2 ml multiple dose vials, an injectable antibiotic; (b) Heparin sets; nc) Lidocaine HCl Injection, USP, 1%, Lock Flush Solution, USP, 100 USP units/ml, for cleaning intermittent infusion sets; (c) Lidocaine HCl Injection, USP, 1%, 10 mg/ml, in 2 ml single dose vials, a local anesthetic for infiltration and nerve block. Recall number: D-401/403-2. Lot numbers: (a) 320148 EXP 2/94; (b) 311367 EXP 12/93; (c) 320057 EXP 7/93. Manufacturer: Lyphomed, Division of Fujisawa USA, Inc., Grand Island, New York. Recalled by: Lyphomed, Division of Fujisawa USA, Inc., Melrose Park, Illinois, by letter June 12, 1992. Firm-initiated recall ongoing. Distribution: Nationwide. (a) 87,775 vials were distributed; firm estimates 10,000 vials remain on the market; (b) 241,100 vials were distributed; firm estimates 60,000 vials remain on the market; (c) 120,900 vials were distributed; firm estimates 61,000 vials remain on the market. Reason: The vials have a low fill volume. CLASS III-- DIAZOXIDE INJECTION, USP 15 mg/ml, in 20 ml single dose vials, a Rx antihypertensive. Recall number: D-404-2. Lot numbers: 120026 EXP 7/93 and 111249 EXP 6/93. Manufacturer: Lyphomed, Division of Fujisawa USA, Inc., Melrose Park, Illinois. Recalled by: Manufacturer, by letter June 17, 1992. Firm-initiated recall ongoing. Distribution: Nationwide. 4,761 vials were distributed; firm estimates 2,380 vials remain on the market. Reason: The pH is below USP limits prior to expiration date.

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