Status
Terminated
Drug Enforcement D-174-2013
Failed Dissolution Specifications; 36 month stability timepoint
Classification
Class II
Report Date
March 6, 2013
Termination Date
January 14, 2014
Product Information
- Product description
- 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
- Product quantity
- 77531 bottles
- Reason for recall
- Failed Dissolution Specifications; 36 month stability timepoint
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- GA
Location & Firm
- Recalling firm
- West-ward Pharmaceutical Corp.
- Address
-
465 Industrial Way W, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-174-2013
- Event ID
- 64106
- Recall initiation date
- December 4, 2012
- Center classification date
- February 27, 2013
- Code info
- 67079A; 67079B; 67079C
- More code info
- —