Drug product
BuPROPion Hydrochloride Extended-Release Tablets, USP (XL) 300 mg, Rx Only, 500-count bottles, Manufactured by Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA inc. Pennington, NJ 08534, NDC 68382-354-05
D-0149-2017
Product summary
- Event
- Event 75696
- Status
- Terminated
- Classification
- Class III
- Quantity
- 2,472 units
- Official record key
drug-enforcement:D-0149-2017
Official wording
Reason: Failed Dissolution Specifications: Product did not meet dissolution specification at an intermediate time point.
Code information: Lot #: MR3365, Exp. Feb 17
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications