FDAFDA · Food and drugs·Recall number D-1574-2014
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
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 # 2A001, Exp. 01/15 Lot # 2A002, Exp. 01/15 Lot # 2C003, Exp. 03/15 Lot # 2F005, Exp. 06/15 Lot # 2G006, Exp. 07/15
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- Canada
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.