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

Recall Number: D-0149-2017

Firm: Zydus Pharmaceuticals USA Inc

Classification: Class III

Status: Terminated

Report Date: 20161130

Initiation Date: 20160803

Termination Date: 20180712

Failed Dissolution Specifications: Product did not meet dissolution specification at an intermediate time point.

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