McKesson Packaging Services recalls buPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, UD 100 Tablets (10 x 10) per carton, Rx only, Mfg By: CMI
Recalled October 10, 2012 · FDA recall D-002-2013 · McKesson Packaging Services
Hazard
Failed USP Dissolution Test Requirements: Possible out-of-specification dissolution results at the 8 hour stability testing point. · FDA Class III
Units
674 cartons
Sold at
Nationwide
Description
Failed USP Dissolution Test Requirements: Possible out-of-specification dissolution results at the 8 hour stability testing point.
Product
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.
Manufacturer(s)
McKesson Packaging Services
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →