FDA Drug Class III — Least Serious

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.

Hazard

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

Products

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, Parsippan
Brand
Wockhardt Usa Inc.
UPC
Lot #: DN10635, Exp 01/15; DM13402, DN10247, Exp 11/14; and DM13449, Exp 07/14

Units Affected

840 bottles