FDA recall D-0207-2017

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

Reason for recall

Failed Dissolution Specifications; 6 month time point

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2016-11-02

Report date

2016-12-28

Termination date

2020-07-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Pennington, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0207-2017