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Recall Observatory FDA recall evidence

Drug product

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.

D-0039-2021

September 11, 2020

Class II

Product summary

Firm
Genesis Partnership Company SA
Event
Event 86427
Status
Ongoing
Classification
Class II
Quantity
5,040 bottles
Official record key
drug-enforcement:D-0039-2021

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 #: 37009, Exp. 02/10/2021

Distribution pattern: Nationwide in the U.S.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations