Wednesday, July 2, 2014

Drugs with Problems July 2, 2014

Drugs Pristiq (desvenlafaxine) Extended-Release Tablets 50 mg, 30 count bottle, Rx only, Distributed by Wyeth Pharmaceuticals, Inc., NDC 0008-1211-30 H74477, H74478, Exp. 03/16, H74479, H79766 Exp. 05/16 Class II Presence of Foreign Tablets/Capsules: Pfizer is recalling 50 mg Pristiq (desvenlafaxine) extended release tablets because a single Pristiq 100 mg tablet was found in a bottle of 50 mg Pristiq. Pfizer Us Pharmaceutical Group
Drugs Gemcitabine For Injection USP, 1 g, (lyophilized), For Intravenous Use Only, Sterile Single Use Vial, Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd, Gujarat, India, NDC 47335-154-40 JKM7188A Class II Lack of Assurance of Sterility: A particle excursion for a different batch of the same product may lead to a lack of sterility assurance. Caraco Pharmaceutical Laboratories, Ltd.
Drugs Dextroamphetamine Sulfate Tablets, USP, 10 mg, 100-count bottles, Rx only, Barr Laboratories, Inc., Pomona, NY 10970, NDC 0555-0953-02. Lot # 34013122A, Exp 11/15 Class II Failed Impurities/Degradation Specifications: this product is being recalled due to an out of specification test result for impurities during stability testing. Teva Pharmaceuticals USA
Drugs Muro 128 (sodium chloride) hypertonicity ophthalmic ointment, 5%, packaged in a) 1 g tube per carton, professional sample, NDC 24208-385-01, UPC 3 24208-385-01 2; b) 1/8 oz. (3.5 g) tube per carton, NDC 24208-385-55, UPC 3 24208-385-55 5; and c) 1/4 oz. (7 g) Twin Pack, Two 1/8 oz. (3.5 g) tubes per carton, NDC 24208-385-56, UPC 3 24208-385-56 3; Bausch & Lomb Incorporated, Tampa, FL 33637. Lot #: a) 179271, Exp 08/14; b) and c) 146791, 146932, Exp 06/14; 151221, 151922, Exp 09/14; 159102, Exp 02/15; 160912, Exp 03/15; 162422, Exp 04/15; 163641, 05/15; 166592, Exp 07/15; 169273, Exp 09/15; 170482, Exp 10/15; 174882, Exp 12/15; 176932, Exp 01/16; 179272, Exp 02/16; 182772, Exp 05/16; 186722, Exp 07/16; 190182, Exp 09/16; and 191631, Exp 10/16 Class II Crystallization: Crystal precipitate formation and an increase in the number of complaints associated with a gritty, sand-like feeling in the eye. Bausch & Lomb, Inc.
Drugs Sodium Chloride Hypertonicity Ophthalmic Ointment, 5%, 1/8 oz. (3.5 g) tube per carton, Distributed by Major Pharmaceuticals, 31778 Enterprise Drive, Livonia, MI 48150, NDC 0904-5315-38, UPC 3 09045 31538 5. Lot #'s: 159101, Exp 02/15; 169271, Exp 09/15; and 170481, Exp 10/15 Class II Crystallization: Crystal precipitate formation and an increase in the number of complaints associated with a gritty, sand-like feeling in the eye. Bausch & Lomb, Inc.

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