Hand Sanitizer Recalled for Acetaldehyde and Acetal Above Limits
Hand Sanitizer LLC is recalling Say Goodbye to Germs hand sanitizer bottles due to CGMP deviations. FDA testing found acetaldehyde and acetal levels above acceptable limits.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with CGMP deviations resulting in acetaldehyde and acetal contamination above specification limits. No illnesses or injuries have been reported, classifying this as a risk-of-harm product where injury has not yet occurred.
Plain-English summary
Hand Sanitizer LLC is recalling Say Goodbye to Germs Alcohol Antiseptic 80% topical hand sanitizer in 12 FL OZ (254 mL) bottles, totaling 24,020 units.
The recall is due to CGMP (Current Good Manufacturing Practice) deviations. FDA testing identified acetaldehyde and acetal levels in the product that exceed FDA specification limits.
Consumers should stop using any bottles from the affected batch numbers (100620-128201 through 100620-128212) and dispose of them safely.
The recalled product
- 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
- Manufacturer
- Hand Sanitizer LLC
- Category
- Drug — Hand Sanitizer
- Hazard
- acetaldehyde
- acetal
- manufacturing-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (12)
- 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
Distribution
Distribution scope not specified by the agency.
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