FDA recall D-1463-2022

Midlab Incorporated · Class II · drug

Product

Maxim Instant Foam Hand Sanitizer (benzalkonium chloride 0.1%) packaged in a) 1 U.S. Gallon (3.78 Liters) drums UPC 7 61841 02502 6 and b) 55 U.S. Gallon drums (208 Liters) UPC 0 07 61841 02504 0, Midlab 140 Private Brand Way, Athens, TN 37303

Reason for recall

CGMP Deviations: Product manufactured using expired active ingredient, Benzalkonium chloride.

Distribution

Naionwide within the United States

Key facts

Status
Terminated
Initiation date
2022-08-08
Report date
2022-08-31
Termination date
2023-08-15
Voluntary/Mandated
Voluntary: Firm initiated
Location
Athens, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1463-2022