Vardenafil HCl recall: CGMP Deviations
Vardenafil HCl, USP (trihydrate), 500 GM Part # 330-05, Rx only, For Manufacturing, Repackaging and Processing for Rx and Research Only, Kalchem…
Why was Vardenafil HCl recalled?
cGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: 070717-1
- Product
- Vardenafil HCl, USP (trihydrate), 500 GM Part # 330-05, Rx only, For Manufacturing, Repackaging and Processing for Rx and Research Only, Kalchem…
- Recalling firm
- Kalchem International, Inc.
- Quantity
- 500 gram jar
- Distribution
- TX
- Recall date
- March 14, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)