Kalchem International, Inc. recalls Vardenafil HCl, USP (trihydrate), 500 GM Part # 330-05, Rx only, For Manufacturing, Repackaging and Processing for Rx an

Recalled March 14, 2018 · FDA recall D-0582-2018 · Kalchem International

Hazard

cGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. · FDA Class II

Units

500 gram jar

Sold at

Description

cGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

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

Manufacturer(s)

Kalchem International, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →