Vardenafil HCl recalled over manufacturing violations

Recall date

February 19, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

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

Recall number

D-0582-2018

FDA classification

Class II

Brand / firm

Kalchem International, Inc.

Sold / distributed

TX

Why it was recalled

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 means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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