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Recall Observatory FDA recall evidence

Drug 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

D-892-2013

February 04, 2013

Class III

Product summary

Firm
American Health Packaging
Event
Event 65457
Status
Terminated
Classification
Class III
Quantity
389 cartons
Official record key
drug-enforcement:D-892-2013

Official wording

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

Code information: The following codes are affects by the recall: Lot #114500, Exipration Date 08/2013, repackaging date 12/04/2011.

Distribution pattern: Nationwide

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    out of specification