April 2022 FDA Recall Drug by Hand Sanitizer Llc
D-1149-2022 - CGMP Deviations

This Class II drug recall was voluntarily initiated by Hand Sanitizer Llc on April 4, 2022 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed in Firm failed to provide distribution pattern information. and the recall is currently terminated.

Recall Number: D-1149-2022

Reason for Recall
CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
Initiated
04-04-2022
Reported
06-22-2022
Quantity
24,020 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89947
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Hand Sanitizer LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Firm failed to provide distribution pattern information.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-17-2024
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Batch# 100620-128201, 100620-128202, 100620-128203, 100620-128204, 100620-128205, 100620-128206, 100620-128207, 100620-128208, 100620-128209, 100620-128210, 100620-128211, 100620-128212