FDA recall D-0791-2021

Charles Paint Research Inc · Class II · drug

Product

HAND SANITIZER (alcohol 80%), Alchol Antiseptic 80% topical solution, Hand Sanitizer non-sterile solution, Net weight (6 lbs 14.2 oz) 1 gallon; Net Quantity (3785 mL), Manufactured by Soapdaddy LLC, 2401 E. 85th Street, Kansas City, MO 64131

Reason for recall

CGMP Deviations: Product manufactured in same facility where product was found to contain acetaldehyde and acetal above the allowable limits.

Distribution

Distributed in Michigan

Key facts

Status
Terminated
Initiation date
2020-09-02
Report date
2021-09-15
Termination date
2023-09-29
Voluntary/Mandated
Voluntary: Firm initiated
Location
Kansas City, MO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0791-2021