PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: June 22, 2022 Initiated: April 4, 2022 #D-1149-2022

Product Description

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.

Details

Recalling Firm
Hand Sanitizer LLC
Units Affected
24,020 bottles
Distribution
Firm failed to provide distribution pattern information.
Location
Lafayette, LA

Frequently Asked Questions

What product was recalled?
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. Recalled by Hand Sanitizer LLC. Units affected: 24,020 bottles.
Why was this product recalled?
CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
Which agency issued this recall?
This recall was issued by the FDA Drug on June 22, 2022. Severity: Moderate. Recall number: D-1149-2022.