Drug product
PAXIL (Paroxetine HCL) Oral Suspension 10 mg/5 mL - 250 mL bottle, Rx Only, Manufactured by GlaxoSmithKline, RTP, NC 27709. Distributed by Apotex Corp., Westin, FL 33326, NDC 60505-0402-5
D-1575-2014
Product summary
- Firm
- Apotex Inc.
- Event
- Event 68967
- Status
- Terminated
- Classification
- Class II
- Quantity
- 13,429 bottles
- Official record key
drug-enforcement:D-1575-2014
Official wording
Reason: Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
Code information: Lot # 2A001, Exp. 01/15; Lot # 2C002, Exp. 03/15
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Foreign material or chemical contamination
Chemical Contamination