Urban Electric Power: Drug Recall

Recall #D-0263-2023 · 01/17/2023

Class II: Risk

Recall Details

Recall Number
D-0263-2023
Classification
Class II
Product Type
Drug
Recalling Firm
Urban Electric Power
Status
Terminated
Date Initiated
01/17/2023
Location
Pearl River, NY, United States
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

Reason for Recall

CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.

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

Distribution Pattern

Nationwide within the United States

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.