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U.S. Department of Health and Human Services

Enforcement Report - Week of October 10, 2012

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Product Detail

Product Description buPROPion Hydrochloride Extended-Release Tablets (XL), 150 mg, UD 100 Tablets (10 x 10) per carton, Rx only, Mfg By: CMIC-VPS Corporation, Cranbury, New Jersey 08512; blister barcode N (01)003 63739 449 10 7, Dist By: McKesson Packaging, Concord, NC 28027; NDC 63739-449-10, carton barcode 6373944910.
Recall Number D-001-2013
Classification Class III
Code Info Lot #: 0074583, Exp. Date 03/12
Product Distributed Qty 187 cartons
Reason For Recall Failed USP Dissolution Test Requirements: Possible out-of-specification dissolution results at the 8 hour stability testing point.

Event Detail

Event Id 63127
Product Type Drugs
Status Completed
Recalling Firm McKesson Packaging Services
City Concord
State NC
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-03-29
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide