Home / Recalls / Actavis Inc / D-855-2013

D-855-2013 Class III Terminated

Recalled by Actavis Inc — Parsippany, NJ

Recall Details

Product Type
Drugs
Report Date
August 14, 2013
Initiation Date
July 31, 2013
Termination Date
May 9, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
15,132 bottles

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.

Reason for Recall

Failed Dissolution Specifications: Dissolution test results at 8 hour time-point were above approved specification limits.

Distribution Pattern

Nationwide and Puerto Rico

Code Information

Lot #: CG2D18A, Exp 06/14

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