FDA recall D-0039-2021

Genesis Partnership Company SA · Class II · drug

Product

Genesis Hand Sanitizer Gel, Topical Solution, Non Sterile Solution, 1 gallon (3785 mL) bottle, Manufactured by Genesis Partnership Company S.A., Guatemala, NDC 74484-002-04, UPC 7401037203427.

Reason for recall

CGMP Deviations: hand sanitizers were recalled because they were manufactured in the same facility as another hand sanitizer product with sub-potent ethanol levels.

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-0039-2021