FDAClass IIJune 22, 2022

HAND SANITIZER SAY GOODBYE TO GERMS Alcohol Antiseptic recall: CGMP Deviations

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

Why was HAND SANITIZER SAY GOODBYE TO GERMS Alcohol Antiseptic recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

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
Recalling firm
Hand Sanitizer LLC
Quantity
24,020 bottles
Distribution
Firm failed to provide distribution pattern information.
Recall date
June 22, 2022
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls