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U.S. Department of Health and Human Services

Enforcement Report - Week of September 4, 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-917-2013
Classification Class III
Code Info Lot #: CA2D14A, CA2D15A, Exp 12/13; CD2D07A, CD2D09A, CD2D10A, CD2D09B, CD2D08A, Exp 03/14; CE2D05A, CE2D06A, CE2D07A, CE2D11A, CE2D12A, CE2D10A, CE2D19A, Exp 04/14; CF2D01A, CF2D02A, CF2D03A, Exp 05/14; CG2D04A, CG2D05A, CG2D07A, CG2D09A, CG2D12A, CG2D12A, Exp 06/14; CH2D13A, CH2D14A, CH2D17A, CH2D18A, CH2D21A, Exp 07/14; CJ2D10A, CJ2D11A, Exp 08/14
Product Distributed Qty 428,268 bottles
Reason For Recall Failed Dissolution Specifications: This recall is an extension of the recall initiated on 07/31/2013 for Bupropion HCl Extended-Release Tablets (XL) 300 mg, because another lot was shown to have similar failing results for dissolution at the 8-hour timepoint.

Event Detail

Event Id 66054
Product Type Drugs
Status Ongoing
Recalling Firm Actavis South Atlantic LLC
City Sunrise
State FL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-08-21
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide and Puerto Rico