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Recall Observatory FDA recall evidence

Drug product

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.

D-0038-2021

September 11, 2020

Class II

Product summary

Firm
Genesis Partnership Company SA
Event
Event 86427
Status
Ongoing
Classification
Class II
Quantity
15,000 bottles
Official record key
drug-enforcement:D-0038-2021

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