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 --

FDA recall notice · announced August 21, 2013 · American Health Packaging

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The product

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

Reason for recall

Failed Stability Specifications; out of specification results at the 9 month stability time point for color, dissolution and related compounds.

Notes

Distribution: Nationwide
Lot/code information: The following codes are affects by the recall: Lot #114500, Exipration Date 08/2013, repackaging date 12/04/2011.
Quantity: 389 cartons
Status: Terminated
Products in this recall event:
- 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 Dis (D-892-2013)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.