FDA recall D-1513-2014

Product

buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 500-count bottle, Rx Only, Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA, LLC, 20 Waterview Blvd, Parsippany, NJ 07054 USA, NDC 64679-101-07.

Reason for recall

Failed Impurities/Degradation Products: Out of specification levels of the impurity m-chlorobenzoic acid were observed.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2014-07-14

Report date

2014-08-13

Termination date

2015-01-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Parsippany, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1513-2014