Why it was recalled
CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
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
Lot numbers, UPCs & expiration codes
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
Where it was sold
Firm failed to provide distribution pattern information.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1149-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 4, 2022
- FDA report date
- Jun 22, 2022
- Quantity
- 24,020 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hand Sanitizer LLC
Original FDA data
Every field from FDA enforcement report D-1149-2022, exactly as published.
Show all FDA fields
- City
- Lafayette
- State
- LA
- Status
- Terminated
- Country
- United States
- Event ID
- 89947
- Address
- 850 Kaliste Saloom Rd Ste 212
- Code 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
- Postal code
- 70508-4230
- Report date
- Jun 22, 2022
- Product type
- Drugs
- Recall number
- D-1149-2022
- Classification
- Class II
- Recalling firm
- Hand Sanitizer LLC
- Product quantity
- 24,020 bottles
- Termination date
- Jun 17, 2024
- Reason for recall
- CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Firm failed to provide distribution pattern information.
- Recall initiation date
- Apr 4, 2022
- Initial firm notification
- Letter
- Center classification date
- Jun 14, 2022