# FDA recall D-0163-2023

> **Fisher Scientific Co., LLC** · Class II · drug recall initiated 2023-01-17.

## Product

Hand Sanitizer, HSANI500ML, (Isopropyl Alcohol), 75% v/v, packaged in a) 500 mL bottle and b) 6 x 500 mL bottles per case, Thermo Fisher Scientific: Janssen Pharmaceuticalaan 3a, 2440 Geel - Belgium, 1 Reagent Lane, Fair Lawn, NJ 07410.

## Reason for recall

CGMP Deviations: Voluntary recall of all hand sanitizer distributed after March 31, 2022, due to FDA issued guidance to cease placing hand sanitizer product, produced under temporary approval, into the market after March 31, 2022.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0163-2023
- **Recalling firm:** Fisher Scientific Co., LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2023-01-17
- **Report date:** 2023-01-25

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Fair Lawn, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0163-2023

## Citation

> AI Analytics. FDA recall D-0163-2023. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/D-0163-2023. Source: US FDA. Licensed CC0.

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