Recall D-0263-2023
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
Recall D-0263-2023 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | D-0263-2023 |
Event ID | 91576 |
Distribution | Nationwide within the United States |
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 Reason | CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits. |
Drug Classification | Class II |
Drug Code Info | 20230215 |
Recall Initiation Date | 20230117 |
Report Date | 20230215 |
Classification Date | 20230208 |
Address | 401 N Middletown Rd Bldg 155 Pearl River, NY 10965-1298 United States |
Recalling Firm | Urban Electric Power |
Initial Notification | Letter |
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