Why it was recalled
CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
Product description
Ohm Hand Sanitizer (alcohol (ethanol) 70 % v/v), packaged in a) 2 FL OZ (60 ML), b) 3 FL OZ (88 ML) bottles, c) 10 FL OZ (295 ML) bottles, d)12 FL OZ (355 ML) bottles, e)16 FL OZ (473 ML) bottles, f) 64 FL OZ (1892 ML) bottles, g) 128 FL OZ (3785 ML) bottles
Lot numbers, UPCs & expiration codes
All lots within expiry
Where it was sold
Nationwide within the United States
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-0263-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 17, 2023
- FDA report date
- Feb 15, 2023
- Quantity
- a) 239 bottles, b) 6,352 bottles, c)14,963 bottles, d) 8,117 bottles, e)22 bottles, f)856 bottles, g) 707 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Urban Electric Power
Original FDA data
Every field from FDA enforcement report D-0263-2023, exactly as published.
Show all FDA fields
- City
- Pearl River
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 91576
- Address
- 401 N Middletown Rd Bldg 155
- Code information
- All lots within expiry
- Postal code
- 10965-1298
- Report date
- Feb 15, 2023
- Product type
- Drugs
- Recall number
- D-0263-2023
- Classification
- Class II
- Recalling firm
- Urban Electric Power
- Product quantity
- a) 239 bottles, b) 6,352 bottles, c)14,963 bottles, d) 8,117 bottles, e)22 bottles, f)856 bottles, g) 707 bottles
- Termination date
- Feb 26, 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
- Ohm Hand Sanitizer (alcohol (ethanol) 70 % v/v), packaged in a) 2 FL OZ (60 ML), b) 3 FL OZ (88 ML) bottles, c) 10 FL OZ (295 ML) bottles, d)12 FL OZ (355 ML) bottles, e)16 FL OZ (473 ML) bottles, f) 64 FL OZ (1892 ML) bottles, g) 128 FL OZ (3785 ML) bottles
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Jan 17, 2023
- Initial firm notification
- Letter
- Center classification date
- Feb 8, 2023