Why it was recalled
CGMP Deviations: Product manufactured in same facility where product was found to contain acetaldehyde and acetal above the allowable limits.
Product description
HAND SANITIZER (alcohol 80%), Alchol Antiseptic 80% topical solution, Hand Sanitizer non-sterile solution, Net weight (6 lbs 14.2 oz) 1 gallon; Net Quantity (3785 mL), Manufactured by Soapdaddy LLC, 2401 E. 85th Street, Kansas City, MO 64131
Lot numbers, UPCs & expiration codes
Lot# 20-151 to 20-159 and 20-161 to20-163, Exp 06/11/2022
Where it was sold
Distributed in Michigan
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-0791-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 2, 2020
- FDA report date
- Sep 15, 2021
- Quantity
- 3,900 gallons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Charles Paint Research Inc
Original FDA data
Every field from FDA enforcement report D-0791-2021, exactly as published.
Show all FDA fields
- City
- Kansas City
- State
- MO
- Status
- Terminated
- Country
- United States
- Event ID
- 88552
- Address
- 2401 E 85th St
- Code information
- Lot# 20-151 to 20-159 and 20-161 to20-163, Exp 06/11/2022
- Postal code
- 64132-2617
- Report date
- Sep 15, 2021
- Product type
- Drugs
- Recall number
- D-0791-2021
- Classification
- Class II
- Recalling firm
- Charles Paint Research Inc
- Product quantity
- 3,900 gallons
- Termination date
- Sep 29, 2023
- Reason for recall
- CGMP Deviations: Product manufactured in same facility where product was found to contain acetaldehyde and acetal above the allowable limits.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- HAND SANITIZER (alcohol 80%), Alchol Antiseptic 80% topical solution, Hand Sanitizer non-sterile solution, Net weight (6 lbs 14.2 oz) 1 gallon; Net Quantity (3785 mL), Manufactured by Soapdaddy LLC, 2401 E. 85th Street, Kansas City, MO 64131
- Distribution pattern
- Distributed in Michigan
- Recall initiation date
- Sep 2, 2020
- Initial firm notification
- Letter
- Center classification date
- Sep 8, 2021