Recalls / Class II
Class IID-1574-2014
Product
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
- Brand name
- Paroxetine Hydrochloride
- Generic name
- Paroxetine Hydrochloride
- Active ingredient
- Paroxetine Hydrochloride
- Route
- Oral
- NDCs
- 60505-1316, 60505-1317, 60505-1318, 60505-3673, 60505-3674, 60505-3675
- FDA application
- NDA020936
- Affected lot / code info
- 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
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-1574-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.