FDA-Drug2016-11-30Class III
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
Zydus Pharmaceuticals USA Inc
Hazard
Failed Dissolution Specifications: Product did not meet dissolution specification at an intermediate time point.
Sold states
Nationwide
Affected count
2,472 units
Manufactured in
73 Route 31 N, N/A, Pennington, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0149-2017Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief