Osmotica Pharmaceutical Corp recalls Venlafaxine (Venlafaxine Hydrochloride) extended release Tablets, 225 mg, packaged in a) 30- count bottle (NDC 0131-3268
Recalled October 9, 2013 · FDA recall D-1067-2013 · Osmotica Pharmaceutical
Hazard
Failed Dissolution Specification:12 hour time point at 18 months of product shelf life. · FDA Class III
Units
57857 bottles
Sold at
Nationwide
Description
Failed Dissolution Specification:12 hour time point at 18 months of product shelf life.
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.
Manufacturer(s)
Osmotica Pharmaceutical Corp
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →