FDA recall D-0037-2021

Genesis Partnership Company SA · Class II · drug

Product

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.

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-0037-2021