FDA recall D-0582-2018

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 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.

Distribution

TX

Key facts

Status

Terminated

Initiation date

2018-02-19

Report date

2018-03-14

Termination date

2020-09-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lindsay, OK, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0582-2018