FDA recall D-0760-2023

Alpha Aromatics · Class II · drug

Product

FOAMING HAND SANITIZER, fresh mint scent, 62% alcohol, 1 Gallon / 3.78 Liters bottle, 290 Alpha Drive RIDC industrial Park, Pittsburgh, PA 15238,

Reason for recall

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

Distribution

Product was distributed to one account in NC.

Key facts

Status
Terminated
Initiation date
2023-05-16
Report date
2023-05-31
Termination date
2024-07-01
Voluntary/Mandated
Voluntary: Firm initiated
Location
Pittsburgh, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0760-2023