FDA Recall Terminated Historical recordClass III
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
- Reason
- Failed Dissolution Specifications: Product did not meet dissolution specification at an intermediate time point.
- Published
- November 30, 2016
- Distribution
- Nationwide
