Recalls / Class II
Class IID-367-2014
Product
Carisoprodol Tablets, USP 350 mg, Rx Only, 1000 tablets. Dist by: West-ward Pharmaceutical Corp. Eatontown, NJ 07724. Mfd by: Shasun Chemicals and Drugs Limited, Unit II, R. S. Na 32, 33, 743 PIMS Rd, Periyakalepet, Pondicherry. 605014 INDIA. NDC 0143-9749-10.
- Affected lot / code info
- NDC 0143-9749-10 Lot: 1) 10BR001B, Exp Aug-2014 2) 10BR002B, Exp Aug-2014 3) 10BR003B Exp, Aug-2014 4) 10BR004B Exp, Aug-2014 5) 10BR005B Exp, Aug-2014 6) 10BR006B Exp, Aug-2014 7) 11BR001B Exp, Aug-2014 8) 11BR002B Exp, Jul-2015 9) 11BR003B Exp, Jul-2015 10) 11BR004B Exp, Jul-2015 11) 11BR005B Exp, Jul-2015 12) 11BR006B Exp, Jul-2015
Why it was recalled
Presence of Foreign Substance; heavy metals (chromium, titanium etc) and inactive components of the product were visually observed during routine stability testing
Recalling firm
- Firm
- West-Ward Pharmaceutical Corp.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 465 Industrial Way W, N/A, Eatontown, New Jersey 07724-2209
Distribution
- Quantity
- 20,534 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-11-07
- FDA classified
- 2013-12-16
- Posted by FDA
- 2013-12-25
- Terminated
- 2014-08-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-367-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.