drugs Class II Updated 2014-09-10

Apotex Inc. recalls Paroxetine HCL Controlled-Release Tablets 25 mg, 30-count bo

Recalled Product

Paroxetine HCL Controlled-Release Tablets 25 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3674-3

Hazard / Issue

Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot # 2A002, Exp. 01/15 Lot # 2A003, Exp. 01/15 Lot # 2C004, Exp. 03/15 Lot # 2C005, Exp. 03/15 Lot # 2E008, Exp. 05/15 Lot # 2F009, Exp. 06/15 Lot # 2F010, Exp. 06/15 Lot # 2H011, Exp. 08/15 Lot # 2H012, Exp. 08/15 Lot # 2H013, Exp. 0815
View official government recall

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