Drug product
Ethambutol Hydrochloride Tablets, USP, 100 mg, 100-count tablets per bottle, Rx only, Mfd. for: Versapharm Incorporated, Marietta, GA; Mfd. by: West-Ward Pharmaceutical Corp., Eatontown, NJ 07724; NDC 61748-011-01.
D-242-2013
Product summary
- Event
- Event 64821
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3, 061 bottles
- Official record key
drug-enforcement:D-242-2013
Official wording
Reason: Subpotent Drug: Out Of Specification results for assay at the stability time-point of 24 months.
Code information: Lot #: 68028A, Exp 07/14
Distribution pattern: Nationwide.
Derived failure modes
-
Potency or specification failure
Subpotent