FDA recall D-1149-2022

Hand Sanitizer LLC · Class II · drug

Product

HAND SANITIZER SAY GOODBYE TO GERMS Alcohol Antiseptic 80% Topical Non-Sterile Solution, 12 FL OZ (254 mL) bottles, Distributed by: Hand Cleansing Gel 850 Kaliste Saloom Rd. Suite 212 Lafayette, LA 70508 UPC 8 60003 62626 9

Reason for recall

CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.

Distribution

Firm failed to provide distribution pattern information.

Key facts

Status
Terminated
Initiation date
2022-04-04
Report date
2022-06-22
Termination date
2024-06-17
Voluntary/Mandated
Voluntary: Firm initiated
Location
Lafayette, LA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1149-2022