FDA recall D-002-2013

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.

Reason for recall

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

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2012-03-29

Report date

2012-10-10

Termination date

2013-04-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Concord, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-002-2013