Recalls / Class II
Class IID-1580-2014
Product
PAXIL (Paroxetine HCL) Tablets 10 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3663-3
- Affected lot / code info
- Lot # 2ZP7113, Exp. 08/15
Why it was recalled
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
Recalling firm
- Firm
- Apotex Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 150 Signet Drive, Toronto, N/A, Canada
Distribution
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2014-03-24
- FDA classified
- 2014-09-03
- Posted by FDA
- 2014-09-10
- Terminated
- 2014-09-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1580-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.