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U.S. Department of Health and Human Services

Enforcement Report - Week of April 24, 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.
Recall Number D-248-2013
Classification Class III
Code Info Lot #: CC1D11A, CC1D12A, CC1D17A, CC1D18A, CD1D05A, CD1D07A, CD1D08A, CD1D14A, CD1D15A, CD1D16A, CE1D08A, Exp 03/13; CE1D03A, CE1D04A, CE1D07A, CE1D06A, CE1D05A, CE1D13A, CE1D14A, CE1D15A, Exp 04/13; CF1D01A, CE1D24A, CF1D02A, Exp 05/13; CH1D08A, CH1D09A, Exp 07/13; CJ1D01A, CH1D11A, CH1D10A, CJ1D09A, CJ1D02A, CJ1D10A Exp 08/13; CL1D05A, CL1D06A, CK1D05B, CK1D06A, Exp 10/13; CL1D08A, CM1D01A, CM1D02A, Exp 11/13
Product Distributed Qty 555,672 bottles
Reason For Recall Failed USP Dissolution Test Requirements: Out-of-specification dissolution results at the 8 hour stability testing point.

Event Detail

Event Id 64846
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 2013-03-20
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide