PlainRecalls
FDA Drug Moderate Class II Ongoing

Panagel Hand Sanitizer, 70% Alcohol,16 Fl. Oz. (472 mL) bottle, Made in Guatemala, Distributed by Central Med Distribution, 6100 Hollywood Blvd, Hollywood FL 33024, NDC 78384-001-04, UPC 378384000016.

Reported: October 28, 2020 Initiated: September 11, 2020 #D-0037-2021

Product Description

Panagel Hand Sanitizer, 70% Alcohol,16 Fl. Oz. (472 mL) bottle, Made in Guatemala, Distributed by Central Med Distribution, 6100 Hollywood Blvd, Hollywood FL 33024, NDC 78384-001-04, UPC 378384000016.

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
33,480 bottles
Distribution
Nationwide in the U.S.
Location
Villa Nueva, N/A

Frequently Asked Questions

What product was recalled?
Panagel Hand Sanitizer, 70% Alcohol,16 Fl. Oz. (472 mL) bottle, Made in Guatemala, Distributed by Central Med Distribution, 6100 Hollywood Blvd, Hollywood FL 33024, NDC 78384-001-04, UPC 378384000016.. Recalled by Genesis Partnership Company SA. Units affected: 33,480 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-0037-2021.