FDA recall D-1067-2013

Product

Venlafaxine (Venlafaxine Hydrochloride) extended release Tablets, 225 mg, packaged in a) 30- count bottle (NDC 0131-3268-32) and b) 90-count bottle (NDC: 0131-3268-46), Rx only, Manufactured by: Kremers Urban Pharmaceuticals Inc. For: Osmotica Pharmaceutical Corp., Wilmington, NC 28405, USA.

Reason for recall

Failed Dissolution Specification:12 hour time point at 18 months of product shelf life.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2013-09-16

Report date

2013-10-09

Termination date

2014-05-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Marietta, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1067-2013