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FDA Recalls & Court Actions: June 13, 1990

Executive Summary

CLASS II -- LYPHOMED MULTI-VITAMIN CONCENTRATE In 5 ml single dose vials, 25 vials per shelf carton, an Rx injectable multivitamin (9 vitamins) for I.V. infusion. Lot numbers: 190428 EXP 5/90, 190811 EXP 9/90, 100022 EXP 1/91, 100128 EXP 2/91. (Also 190496 and 100042 distributed only in Canada). Manufacturer: Lyphomed, Inc., Melrose Park, Illinois. Recalled by: Lyphomed, Inc., Rosemont, Illinois, by letter April 20, 1990. Firm-initiated recall ongoing. Distribution: Nationwide, Puerto Rico, Hong Kong, Israel, Canada. 575,825 vials were distributed in the United States. Reason: Some units were found to have leakage around the metal closure which secures the metal stopper. CLASS II -- UDL BRAND AMOXICILLIN (AMOXICILLIN TRIHYDRATE) CAPSULES 500 mg, in unit dose cards of 10 in cartons containing 10 cards, an Rx semisynthetic pencillin. Lot number 21584 EX 8/1/91. Manufacturer: Biocraft Laboratories, Elmwood Park, New Jersey. Recalled by: Manufacturer, by letter May 14, 1990. Firm-initiated recall ongoing. Distribution: Distributed through one own-label distributor nationwide. 4,480 unit dose capsules were distributed. Reason: Mislabeling -- A package of 100 unit dose capsules of Amoxicillin 500 mg was found mislabeled as Oxacillin capsules 500 mg. The individual capsules were correctly labeled. CLASS II -- CORRECTION: Isosorbide Dinitrate Sublingual Tablets, USP, 5 mg, Lot number 9B173AR EXP 4/92 which appeared in the June 6, 1990 Enforcement Report ["The Pink Sheet" June 11, T&G-17]: The recall applies only to product distributed under the Qualitest label.

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