Recall: 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 Details

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