drugs Class III Updated 2014-08-13

Wockhardt Usa Inc. recalls buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 50

Recalled 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.

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot #: DN10635, Exp 01/15; DM13402, DN10247, Exp 11/14; and DM13449, Exp 07/14
View official government recall

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