Status
Terminated
Drug Enforcement D-0264-2023
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 Sanitizer Spray (alcohol (ethyl alcohol) 80% v/v, 8 FL OZ (237 ML) bottles.
- Product quantity
- 609 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-0264-2023
- Event ID
- 91576
- Recall initiation date
- January 17, 2023
- Center classification date
- February 8, 2023
- Code info
- All lots within expiry
- More code info
- —