Recalls / Class II
Class IID-174-2013
Product
Isoniazid Tablets 300 mg tablets USP, Rx Only, a) 30 tablets - NDC 61748-013-30, b) 100 tablets - NDC 61748-013-01, Mfd for: VersaPharm Incorporated Marietta, GA 30065-1505, Mfd by: West - Ward Pharmaceutical Corp.., Eatontown, NJ 07724
- Affected lot / code info
- 67079A; 67079B; 67079C
Why it was recalled
Failed Dissolution Specifications; 36 month stability timepoint
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
- 77531 bottles
- Distribution pattern
- GA
Timeline
- Recall initiated
- 2012-12-04
- FDA classified
- 2013-02-27
- Posted by FDA
- 2013-03-06
- Terminated
- 2014-01-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-174-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.