Home / Recalls / Kalchem International, Inc. / D-0582-2018

D-0582-2018 Class II Terminated

Recalled by Kalchem International, Inc. — Lindsay, OK

Recall Details

Product Type
Drugs
Report Date
March 14, 2018
Initiation Date
February 19, 2018
Termination Date
September 15, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
500 gram jar

Product Description

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.

Distribution Pattern

TX

Code Information

Lot #: 070717-1