FDA Recall Terminated Historical recordClass III
buPROPion Hydrochloride Extended-Release Tablets, USP (XL), 300mg, 500-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India For BluePoint Laboratories, NDC 68001-264-03
- Reason
- Failed dissolution specifications - the out of specification result for dissolution was identified during 3 month stability testing.
- Published
- September 21, 2016
- Distribution
- Nationwide
