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08-27-2013, 08:41 PM #1
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Recall: buPROPion Hydrochloride Extended Release Tablets, USP 100 mg
Product Detail
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
Recall Number D-892-2013
Classification Class III
Code Info The following codes are affects by the recall: Lot #114500, Exipration
Date 08/2013, repackaging date 12/04/2011.
Product Distributed Qty 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.
Event Detail
Event Id 65457
Product Type Drugs
Status Ongoing
Recalling Firm
American Health Packaging
City Columbus
State OH
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-02-04
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide
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