Zydus Pharmaceuticals USA Inc recalls BuPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, Rx Only, a) 30 count bottles (NDC 68382-354-06) and b) 5…

Recall date

November 2, 2016

Source

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

Recall number

D-0207-2017

FDA classification

Class III

Brand / firm

Zydus Pharmaceuticals USA Inc

Sold / distributed

Nationwide

Why it was recalled

Failed Dissolution Specifications; 6 month time point

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

What was recalled

BuPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, Rx Only, a) 30 count bottles (NDC 68382-354-06) and b) 500 count bottles (NDC 68382-354-05), Manufactured by: Cadila Healthcare LTD. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534