# FDA recall D-0458-2020

> **Altaire Pharmaceuticals, Inc.** · Class II · drug recall initiated 2019-07-02.

## Product

Accutome Rx Accu-WASH, 4 FL OZ (118 mL), Manufactured for Accutome Inc 3222 Phoenixville Pike Malvern, PA 19355 USA Mfd. By: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931,  NDC 63448-411-04

## Reason for recall

Lack of Assurance of Sterility

## Distribution

U.S.A. Nationwide

## Key facts

- **Recall number:** D-0458-2020
- **Recalling firm:** Altaire Pharmaceuticals, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Completed
- **Initiation date:** 2019-07-02
- **Report date:** 2019-11-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Aquebogue, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0458-2020

## Citation

> AI Analytics. FDA recall D-0458-2020. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/D-0458-2020. Source: US FDA. Licensed CC0.

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