Drug 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.
D-1513-2014
Product summary
- Event
- Event 68813
- Status
- Terminated
- Classification
- Class III
- Quantity
- 840 bottles
- Official record key
drug-enforcement:D-1513-2014
Official wording
Reason: Failed Impurities/Degradation Products: Out of specification levels of the impurity m-chlorobenzoic acid were observed.
Code information: Lot #: DN10635, Exp 01/15; DM13402, DN10247, Exp 11/14; and DM13449, Exp 07/14
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Out of specification