FDA Drug recall D-0582-2018
Vardenafil HCl, USP (trihydrate), 500 GM Part # 330-05, Rx only, For Manufacturing, Repackaging and Processing for Rx and Research Only, Ka…
- FDA Drug
- Class II
- terminated
- Published 2018-03-14
On 2018-03-14 the FDA classified a Class II recall of Vardenafil HCl, USP (trihydrate), 500 GM Part # 330-05, Rx only, For Manufacturing, Repackaging and Processing for Rx and Research Only, Ka… by Kalchem International, citing cGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0582-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-02-19 |
| Published | 2018-03-14 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Kalchem International |
| Distribution | TX |
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
Reason
cGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Identifiers
| code_info | Lot #: 070717-1 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0582-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.