Class III
Terminated
buPROPion Hydrochloride Extended Release Tablets, USP 100 mg, 100 count carton, 10 blister cards of 10 individually blistered and labeled tablets, Rx only, Actavis South Atlantic LLC, Packaged and Distributed by: American Health Packaging, Columbus, OH --- NDC 68084-470-01
- Company
- American Health Packaging
- Recall Initiated
- February 4, 2013
- Posted
- August 21, 2013
- Recall Number
- D-892-2013
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 389 cartons
- Firm Location
- Columbus, OH, United States
Reason for Recall
Failed Stability Specifications; out of specification results at the 9 month stability time point for color, dissolution and related compounds.
Distribution
Nationwide
Lot / Code Info
The following codes are affects by the recall: Lot #114500, Exipration Date 08/2013, repackaging date 12/04/2011.
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