Drug product
VERSAPHARM INCORPORATED Ethambutol Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx Only, Manufactured for VersaPharm Incorporated Marietta, GA 30065-1509 Manufactured by West-ward Pharmaceutical Corp. Eatontown, NJ 07724, NDC 61748-011-01
D-0172-2015
Product summary
- Event
- Event 69539
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5,596 HDPE bottles
- Official record key
drug-enforcement:D-0172-2015
Official wording
Reason: Subpotency: Out of Specification (OOS) result at the 36 month routine stability time point.
Code information: Lot #68975A, #68976; Exp. 07/15
Distribution pattern: GA
Derived failure modes
-
Potency or specification failure
Subpotency