FDA recall D-0263-2023

Product

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

Nationwide within the United States

Key facts

Status

Terminated

Initiation date

2023-01-17

Report date

2023-02-15

Termination date

2024-02-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Pearl River, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0263-2023