Zydus Pharmaceuticals USA Inc recalls BuPROPion Hydrochloride Extended-Release Tablets, USP (XL) 300 mg, Rx Only, 500-count bottles, Manufactured by Cadila
Recalled November 30, 2016 · FDA recall D-0149-2017 · Zydus Pharmaceuticals USA
Hazard
Failed Dissolution Specifications: Product did not meet dissolution specification at an intermediate time point. · FDA Class III
Units
2,472 units
Sold at
Nationwide
Description
Failed Dissolution Specifications: Product did not meet dissolution specification at an intermediate time point.
Product
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
Manufacturer(s)
Zydus Pharmaceuticals USA Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →