Drug 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
D-174-2013
Product summary
- Event
- Event 64106
- Status
- Terminated
- Classification
- Class II
- Quantity
- 77531 bottles
- Official record key
drug-enforcement:D-174-2013
Official wording
Reason: Failed Dissolution Specifications; 36 month stability timepoint
Code information: 67079A; 67079B; 67079C
Distribution pattern: GA
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications