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FDA RECALLS & COURT ACTIONS: April 1, 1992

Executive Summary

CLASS III -- BENZTROPINE MESYLATE TABLETS 0.5 mg, repacked into unit dose containers. Recall number: D-280-2. Lot numbers: 2547-018 9/92, 2547-019 10/92, 2547-020 10/92. Manufacturer: Sidmak Laboratories, Inc., East Hanover, New Jersey. Recalled by: Vangard Labs, Inc., Glasgow, Kentucky (repacker). Firm- initiated recall ongoing. Distribution: Nationwide. Firm estimates 6,800 tablets remain on the market. Reason: Product does not meet USP content uniformity specifications. CLASS III -- CALAMINE LOTION In 4 and 8 ounce bottles, an OTC topical drug. Recall number: D-278- 2. All lots in date. Manufacturer: Barre-National, Inc., Baltimore, Maryland. Recalled by: Manufacturer, by letter Jan. 30, 1992. Firm- initiated recall ongoing. Distribution: Nationwide, Bahamas, Guam. 494,798 units were distributed; firm estimates 9,364 units remain on the market. Reason: Product does not meet stability specifications. CLASS III -- PROMETH WITH CODEINE In 4 and 16 ounce bottles, a Rx drug indicated for the temporary relief of cough and upper respiratory symptoms associated with allergies or the common cold. Recall number: D-279-2. Lot number 03659 EXP 06/92. Manufacturer: Barre-National, Inc., Baltimore, Maryland. Recalled by: Manufacturer, by letter Jan. 30, 1992. Firm- initiated recall ongoing. Distribution: Nationwide. 128,861 units were distributed; firm estimates 24 units remain on the market. Reason: Subpotency of promethazine ingredient.

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