D-0263-2023 Class II Terminated
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
- a) 239 bottles, b) 6,352 bottles, c)14,963 bottles, d) 8,117 bottles, e)22 bottles, f)856 bottles, g) 707 bottles
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
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