FDAFDA · Food and drugs·Recall number D-1576-2014
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
Published September 10, 2014 · Recall initiated: March 24, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- PAROXETINE HYDROCHLORIDE
- Manufacturer
- Apotex Inc.
- Distributor
- Nationwide and Puerto Rico
- UPC
- 0360505367436
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- Canada
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