FDA recall D-0040-2021

Genesis Partnership Company SA · Class II · drug

Product

Killz Germz Hand Sanitizer, Alcohol Gel, 450 mL (15 fl oz.) bottle, Manufactured by Genesis Partnership Company S.A., Guatemala, For: Killz Germz, LLC., 1912 R street NW, Washington DC, 20009, NDC 74625-003-04, UPC 7401037203250.

Reason for recall

Sub-Potent Drug; Killz GERMz was recalled due to sub-potent results. Testing revealed ethanol levels as low as 62% while labelled claim is 70%.

Distribution

Nationwide in the U.S.

Key facts

Status
Ongoing
Initiation date
2020-09-11
Report date
2020-10-28
Voluntary/Mandated
Voluntary: Firm initiated
Location
Villa Nueva, N/A, Guatemala

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0040-2021