D-0264-2023 Class II Terminated
FDA drug recall D-0264-2023 was initiated by Urban Electric Power on January 17, 2023 and is designated Class II. Reason for recall: CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits. The recall status is terminated (terminated February 26, 2024). Affected quantity: 609 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- February 15, 2023
- Initiation Date
- January 17, 2023
- Termination Date
- February 26, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 609 bottles
Product Description
Ohm Sanitizer Spray (alcohol (ethyl alcohol) 80% v/v, 8 FL OZ (237 ML) bottles.
Reason for Recall
CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
Distribution Pattern
Nationwide within the United States
Code Information
All lots within expiry