Recalls / Class II
Class IID-1578-2014
Product
PAXIL CR (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 60505-3669-3
- Brand name
- Paxil
- Generic name
- Paroxetine Hydrochloride
- Active ingredient
- Paroxetine Hydrochloride
- Route
- Oral
- NDCs
- 60505-4377, 60505-4378, 60505-4379, 60505-3668, 60505-3669, 60505-3670
- FDA application
- NDA020936
- Affected lot / code info
- Lot # 2F004, Exp. 06/15
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.
- Manufacturer
- Apotex Corp
- 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-1578-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.