Product: Vardenafil HCl, USP (trihydrate), 500 GM Part # 330-05, Rx only, For Manufacturing, Repackaging and Processing for Rx and Research Only, Kalchem International, Inc. 224 South Main Street Lindsay, OK 73052 888-298-9905, NDC 60592-330-05
Reason for recall: cGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Recall initiated: 20180219
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated