Drug Enforcement D-892-2013

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

Status

Terminated

Classification

Class III

Report Date

August 21, 2013

Termination Date

August 28, 2013

Product Information

Product description
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
Product quantity
389 cartons
Reason for recall
Failed Stability Specifications; out of specification results at the 9 month stability time point for color, dissolution and related compounds.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide

Location & Firm

Recalling firm
American Health Packaging
Address
2550 John Glenn Ave, Suite A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-892-2013
Event ID
65457
Recall initiation date
February 4, 2013
Center classification date
August 15, 2013
Code info
The following codes are affects by the recall: Lot #114500, Exipration Date 08/2013, repackaging date 12/04/2011.
More code info
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