RecallDepth
Class III Terminated

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.

Company
Mckesson Packaging Services
Recall Initiated
March 29, 2012
Posted
October 10, 2012
Recall Number
D-002-2013
Voluntary / Mandated
Voluntary: Firm initiated
Quantity
674 cartons
Firm Location
Concord, NC, United States

Reason for Recall

Failed USP Dissolution Test Requirements: Possible out-of-specification dissolution results at the 8 hour stability testing point.

Distribution

Nationwide

Lot / Code Info

Lot #: 0075375, 0074584, Exp 08/12

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