Kalchem International recalls

FDA enforcement reports naming Kalchem International, Inc. as the recalling firm.

Recall reports: 1
Class I (serious): 0
Most recent report: Mar 14, 2018

Severity

Mar 14, 2018Vardenafil HCl, USP (trihydrate), 500 GM Part # 330-05, Rx only, For Manufacturing, Rep…Drug · Kalchem International, Inc.cGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.Class II