D-1513-2014 Class III Terminated
FDA drug recall D-1513-2014 was initiated by Wockhardt Usa Inc. on Jul 14, 2014 and is designated Class III. Reason for recall: Failed Impurities/Degradation Products: Out of specification levels of the impurity m-chlorobenzoic acid were observed. The recall status is terminated (terminated Jan 12, 2015). Affected quantity: 840 bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Aug 13, 2014
- Initiation Date
- Jul 14, 2014
- Termination Date
- Jan 12, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 840 bottles
Product description
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.
Reason for recall
Failed Impurities/Degradation Products: Out of specification levels of the impurity m-chlorobenzoic acid were observed.
Distribution pattern
Nationwide
Code information
Lot #: DN10635, Exp 01/15; DM13402, DN10247, Exp 11/14; and DM13449, Exp 07/14
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1513-2014
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026