FDA recall D-0163-2023

Fisher Scientific Co., LLC · Class II · drug

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

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-0163-2023