FDA recall D-0149-2017

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

Reason for recall

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

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2016-08-03

Report date

2016-11-30

Termination date

2018-07-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Pennington, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0149-2017