Recalls / Class III
Class IIID-1513-2014
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.
- Affected lot / code info
- Lot #: DN10635, Exp 01/15; DM13402, DN10247, Exp 11/14; and DM13449, Exp 07/14
Why it was recalled
Failed Impurities/Degradation Products: Out of specification levels of the impurity m-chlorobenzoic acid were observed.
Recalling firm
- Firm
- Wockhardt Usa Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 20 Waterview Blvd., Suite 3, N/A, Parsippany, New Jersey 07054
Distribution
- Quantity
- 840 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-07-14
- FDA classified
- 2014-08-05
- Posted by FDA
- 2014-08-13
- Terminated
- 2015-01-12
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1513-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.