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.
Recall initiated: 20130916
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated