PlainRecalls
FDA Drug Moderate Class II Ongoing

Genesis Hand Sanitizer Gel, Topical Solution, Non Sterile Solution, 240 mL (8 FL OZ.) bottle, Manufactured by Genesis Partnership Company S.A., Guatemala, NDC 74484-002-02, UPC 7401037205773.

Reported: October 28, 2020 Initiated: September 11, 2020 #D-0038-2021

Product Description

Genesis Hand Sanitizer Gel, Topical Solution, Non Sterile Solution, 240 mL (8 FL OZ.) bottle, Manufactured by Genesis Partnership Company S.A., Guatemala, NDC 74484-002-02, UPC 7401037205773.

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
15,000 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, 240 mL (8 FL OZ.) bottle, Manufactured by Genesis Partnership Company S.A., Guatemala, NDC 74484-002-02, UPC 7401037205773.. Recalled by Genesis Partnership Company SA. Units affected: 15,000 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-0038-2021.