Status
Terminated
Drug Enforcement D-0263-2023
CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
Classification
Class II
Report Date
February 15, 2023
Termination Date
February 26, 2024
Product Information
- 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
- 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
- Reason for recall
- CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide within the United States
Location & Firm
- Recalling firm
- Urban Electric Power
- Address
-
401 N Middletown Rd Bldg 155
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0263-2023
- Event ID
- 91576
- Recall initiation date
- January 17, 2023
- Center classification date
- February 8, 2023
- Code info
- All lots within expiry
- More code info
- —