FDAFDA · Food and drugs·Recall number D-1513-2014
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.
Published August 13, 2014 · Recall initiated: July 14, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Products: Out of specification levels of the impurity m-chlorobenzoic acid were observed.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Wockhardt Usa Inc.
- Distributor
- Nationwide
- Lot
- Lot #: DN10635, Exp 01/15; DM13402, DN10247, Exp 11/14; and DM13449, Exp 07/14
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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