Wockhardt Usa Inc. recalls buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 500-count bottle, Rx Only, Manufactured by: Wockhardt Limited,
Recalled August 13, 2014 · FDA recall D-1513-2014 · Wockhardt Usa
Hazard
Failed Impurities/Degradation Products: Out of specification levels of the impurity m-chlorobenzoic acid were observed. · FDA Class III
Units
840 bottles
Sold at
Nationwide
Description
Failed Impurities/Degradation Products: Out of specification levels of the impurity m-chlorobenzoic acid were observed.
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.
Manufacturer(s)
Wockhardt Usa Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →