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Recall D-1149-2022

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

Recall D-1149-2022 Information

Mandated?Voluntary: Firm initiated
Recall NumberD-1149-2022
Event ID89947
DistributionFirm failed to provide distribution pattern information.
Quantity24,020 bottles
Recall ReasonCGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
Drug ClassificationClass II
Drug Code Info20220622
Recall Initiation Date20220404
Report Date20220622
Classification Date20220614
Address850 Kaliste Saloom Rd Ste 212
Lafayette, LA 70508-4230
United States
Recalling FirmHand Sanitizer LLC
Initial Notification Letter
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