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U.S. Department of Health and Human Services

Enforcement Report - Week of October 10, 2012

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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

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. Lot #: 0074583, Exp. Date 03/12 Class III Failed USP Dissolution Test Requirements: Possible out-of-specification dissolution results at the 8 hour stability testing point. 187 cartons D-001-2013
buPROPion Hydrochloride Extended-Release Tablets (XL), 300 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 450 10 3, Dist By: McKesson Packaging, Concord, NC 28027; NDC 63739-450-10, carton barcode 6373945010. Lot #: 0075375, 0074584, Exp 08/12 Class III Failed USP Dissolution Test Requirements: Possible out-of-specification dissolution results at the 8 hour stability testing point. 674 cartons D-002-2013
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