Drug Enforcement D-917-2013

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.

Status

Terminated

Classification

Class III

Report Date

September 4, 2013

Termination Date

April 10, 2014

Product Information

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.
Product quantity
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.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide and Puerto Rico

Location & Firm

Recalling firm
Actavis South Atlantic LLC
Address
13800 Nw 2nd St Ste 190

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

Codes & Dates

Recall number
D-917-2013
Event ID
66054
Recall initiation date
August 21, 2013
Center classification date
August 23, 2013
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
More code info
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