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

Recall Number: D-1501-2016

Firm: Amerisource Health Services

Classification: Class III

Status: Terminated

Report Date: 20160921

Initiation Date: 20160804

Termination Date: 20170717

Failed dissolution specifications - the out of specification result for dissolution was identified during 3 month stability testing.

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