Product: 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 for recall: Failed dissolution specifications - the out of specification result for dissolution was identified during 3 month stability testing.
Recall initiated: 20160804
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated