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Recall Observatory FDA recall evidence

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.

D-0037-2021

September 11, 2020

Class II

Product summary

Firm
Genesis Partnership Company SA
Event
Event 86427
Status
Ongoing
Classification
Class II
Quantity
33,480 bottles
Official record key
drug-enforcement:D-0037-2021

Official wording

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

Code information: Lot #: 072120, Exp. 01/21/2022

Distribution pattern: Nationwide in the U.S.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations