FDA Recall Terminated Historical recordClass III
BuPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, Rx Only, a) 30 count bottles (NDC 68382-354-06) and b) 500 count bottles (NDC 68382-354-05), Manufactured by: Cadila Healthcare LTD. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534
- Reason
- Failed Dissolution Specifications; 6 month time point
- Published
- December 28, 2016
- Distribution
- Nationwide
