Drug product
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
D-0582-2018
Product summary
- Event
- Event 79304
- Status
- Terminated
- Classification
- Class II
- Quantity
- 500 gram jar
- Official record key
drug-enforcement:D-0582-2018
Official wording
Reason: cGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Code information: Lot #: 070717-1
Distribution pattern: TX
Derived failure modes
-
Manufacturing or process control
cGMP Deviations