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U.S. Department of Health and Human Services

Enforcement Report - Week of August 14, 2013

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Product Detail

Product Description BuPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, 30-count tablets per bottle, Rx only, Distributed by: Actavis South Atlantic, LLC, Sunrise, FL 33325; Packaged by: American Health Packaging, Columbus, OH 43217, NDC 67767-142-30, UPC 3 67767-142-30 6.
Recall Number D-855-2013
Classification Class III
Code Info Lot #: CG2D18A, Exp 06/14
Product Distributed Qty 15,132 bottles
Reason For Recall Failed Dissolution Specifications: Dissolution test results at 8 hour time-point were above approved specification limits.

Event Detail

Event Id 65881
Product Type Drugs
Status Ongoing
Recalling Firm Actavis Inc
City Parsippany
State NJ
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-07-31
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide and Puerto Rico