drugs Class II Updated 2014-09-10

Apotex Inc. recalls Paroxetine HCL Controlled-Release Tablets 12.5 mg, 30-count

Recalled Product

Paroxetine HCL Controlled-Release Tablets 12.5 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3673-3

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 # 2A001, Exp. 01/15 Lot # 2A002, Exp. 01/15 Lot # 2C003, Exp. 03/15 Lot # 2F005, Exp. 06/15 Lot # 2G006, Exp. 07/15
View official government recall

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