PlainRecalls
FDA Drug Moderate Class II Ongoing

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.

Reported: October 28, 2020 Initiated: September 11, 2020 #D-0039-2021

Product Description

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.

Details

Units Affected
5,040 bottles
Distribution
Nationwide in the U.S.
Location
Villa Nueva, N/A

Frequently Asked Questions

What product was recalled?
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.. Recalled by Genesis Partnership Company SA. Units affected: 5,040 bottles.
Why was this product recalled?
CGMP Deviations: hand sanitizers were recalled because they were manufactured in the same facility as another hand sanitizer product with sub-potent ethanol levels.
Which agency issued this recall?
This recall was issued by the FDA Drug on October 28, 2020. Severity: Moderate. Recall number: D-0039-2021.