FDA recall D-0164-2023

Product

Hand Sanitizer, HSANI4LI, (Isopropyl Alcohol), 75% Topical Solution, packaged in 4 L bottles, 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

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

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0164-2023