# FDA recall D-0582-2018

> **Kalchem International, Inc.** · Class II · drug recall initiated 2018-02-19.

## 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

- **Recall number:** D-0582-2018
- **Recalling firm:** Kalchem International, Inc.
- **Classification:** Class II
- **Product type:** drug
- **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

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

## Citation

> AI Analytics. FDA recall D-0582-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-0582-2018. Source: US FDA. Licensed CC0.

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