Lindsay, OK, United States
Kalchem International, Inc. recalls
1 recall recorded since 2018, most recently on 19 February 2018. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Drugs
- Recall started
- 19 February 2018
- Terminated
- 15 September 2020
- Reason
- cGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
- Distribution
- TX
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0582-2018
- 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, N
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.