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U.S. Department of Health and Human Services

Enforcement Report - Week of March 6, 2013

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Product Detail

Product Description buPROPion Hydrochloride Extended - Release Tablets (XL) 300 mg, 30 tablet bottles, Rx Only, NDC 67767-142-30 Actavis Distributed by: Actavis South Atlantic LLC Sunrise, FL 33325 Packaged by by: America Health Packaging Columbus, OH 43217
Recall Number D-175-2013
Classification Class III
Code Info Lot CB1D05A,
Product Distributed Qty 14,856 bottles
Reason For Recall Failed Dissolution Specifications; 8-hours for the 18-month stability testing point.

Event Detail

Event Id 64317
Product Type Drugs
Status Ongoing
Recalling Firm Actavis Pharmaceuticals
City Morristown
State NJ
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-01-04
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide