Recalls / Class III
Class IIID-201-2013
Product
Carisoprodol Tablets, USP, 350 mg Rx Only, 100 tablets per bottle, Rx Only, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724, NDC 0143-1176-01.
- Affected lot / code info
- Lot #: 69160A
Why it was recalled
Labeling: Not elsewhere classified: On 12/12/11, DEA published a final rule in the Federal Register making this product a schedule IV (C-IV)controlled substance. This product is being recalled because this controlled product was not relabeled with the required "C-IV" imprint on the label for products distributed after the 06/11/12 deadline.
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
- 1763 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2012-11-30
- FDA classified
- 2013-03-15
- Posted by FDA
- 2013-03-27
- Terminated
- 2014-12-18
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-201-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.