FDAFebruary 19, 2018drug
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
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
cGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
What to do
FDA enforcement status: Terminated
Brands named
kalchem
Recall history
No related federal recalls on record for this brand yet.
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