Recalls / Class II
Class IID-150-2013
Product
Carisoprodol Tablets, USP, 350 mg, packaged in a) 500-count tablets per bottle (NDC 0143-1176-05) and b) 1000-count tablets per bottle (NDC 0143-1176-10), Rx only, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724.
- Affected lot / code info
- Lot #: 69364A, 69365A, and 69365B, Exp 10/15
Why it was recalled
Presence of Foreign Substance: Uncharacteristic blacks spots on tablets.
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
- 8,585 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2012-12-07
- FDA classified
- 2013-02-05
- Posted by FDA
- 2013-02-13
- Terminated
- 2014-12-18
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-150-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.