Drug product
Teva Ethambutol Hydrochloride Tablets, USP, 400 mg, 100- count bottle, Rx Only,Distributed by Teva Pharmaceuticals, USA, Sellersville, PA., NDC 0555-0923-02.
D-1092-2014
Product summary
- Event
- Event 67412
- Status
- Terminated
- Classification
- Class II
- Quantity
- 10405 tablets
- Official record key
drug-enforcement:D-1092-2014
Official wording
Reason: CGMP Deviations: Ethambutol Hydrochloride Tablets, USP, 400 mg were manufactured using unapproved material: the incorrect gelatin excipient than specified in the product formulation.
Code information: Lot # 34013698A, Exp. 01/16. Lot # 34013699A, Exp. 01/16. Lot # 34013700A, Exp. 01/16. Lot # 34013756A, Exp. 01/16.
Distribution pattern: Nationwide.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations