Class III
Terminated
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.
- Company
- Wockhardt Usa Inc.
- Recall Initiated
- July 14, 2014
- Posted
- August 13, 2014
- Recall Number
- D-1513-2014
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 840 bottles
- Firm Location
- Parsippany, NJ, United States
Reason for Recall
Failed Impurities/Degradation Products: Out of specification levels of the impurity m-chlorobenzoic acid were observed.
Distribution
Nationwide
Lot / Code Info
Lot #: DN10635, Exp 01/15; DM13402, DN10247, Exp 11/14; and DM13449, Exp 07/14
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