Drug product
ZyGenerics ATENOLOL Tablets, USP 25 mg 1000 count bottle, Rx Only Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08634 USA NDC 68382-022-01
D-0007-2015
Product summary
- Event
- Event 68988
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5400 bottles
- Official record key
drug-enforcement:D-0007-2015
Official wording
Reason: Superpotent Drug: A complaint was reported by a pharmacist who stated several tablets were noticeably thicker in appearance.
Code information: MP2292 Exp. 01/16
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Superpotent