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)
Recalled December 28, 2016 · FDA recall D-0207-2017 · Zydus Pharmaceuticals USA
Hazard
Failed Dissolution Specifications; 6 month time point · FDA Class III
Units
16,356 bottles
Sold at
Nationwide
Description
Failed Dissolution Specifications; 6 month time point
Product
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
Manufacturer(s)
Zydus Pharmaceuticals USA Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →