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
Reported: March 14, 2018 Initiated: February 19, 2018 #D-0582-2018
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.
Details
- Recalling Firm
- Kalchem International, Inc.
- Units Affected
- 500 gram jar
- Distribution
- TX
- Location
- Lindsay, OK
Frequently Asked Questions
What product 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. Recalled by Kalchem International, Inc.. Units affected: 500 gram jar.
Why was this product recalled? ▼
cGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 14, 2018. Severity: Moderate. Recall number: D-0582-2018.
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