FDA Drug Recalls

Recalls / Class II

Class IID-0040-2021

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.

Affected lot / code info
Lot #s: 36748, 36818, 36697, Exp. 10/15/21 and 11/8/21

Why it was recalled

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%.

Recalling firm

Firm
Genesis Partnership Company SA
Notification channel
Letter
Type
Voluntary: Firm initiated
Address
Km 19.5 Carretera Al Pacifico, Bodega 28, N/A, Villa Nueva, N/A N/A, Guatemala

Distribution

Quantity
5,320 bottles
Distribution pattern
Nationwide in the U.S.

Timeline

Recall initiated
2020-09-11
FDA classified
2020-10-19
Posted by FDA
2020-10-28
Status
Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-0040-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.

Class II recall: drug · FDA Drug Recalls