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
Check against the official notice below — it lists the full affected range.
Apotex Inc. is recalling Paroxetine HCL Controlled-Release Tablets 25 mg in 30-count bottles distributed nationwide and in Puerto Rico. The recall affects nine lots of the medication manufactured by GlaxoSmithKline in Research Triangle Park, North Carolina, for Apotex Corp. in Weston, Florida. The affected lot numbers are 2A002, 2A003, 2C004, 2C005, 2E008, 2F009, 2F010, 2H011, 2H012, and 2H013, with expiration dates ranging from January 2015 through August 2015.
The recall was issued because the active pharmaceutical ingredient batches used to manufacture these tablets were contaminated with residual materials and solvents. The source document does not specify what actions affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
Reason for recall: Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents. Distribution: Nationwide and Puerto Rico 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
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.