Zydus Pharmaceuticals USA Inc recalls BuPROPion Hydrochloride Extended-Release Tablets, USP (XL) 300 mg, Rx Only, 500-count bottles, Manufactured by Cadila H…

Recall date

August 3, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0149-2017

FDA classification

Class III

Brand / firm

Zydus Pharmaceuticals USA Inc

Sold / distributed

Nationwide

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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