The Recall Desk
ModerateFDA (Drugs)·D-0039-2021·Announced 2020-10-28

Genesis Hand Sanitizer Gel Recalled for CGMP Deviations

Genesis Partnership Company SA is recalling 5,040 bottles of hand sanitizer gel due to manufacturing deviations in a facility that produced sub-potent products.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically involves a situation where use of, or exposure to, a violative product may cause temporary or medically reversible health consequences. The hazard is a manufacturing deviation (sub-potent ethanol) without reported illnesses, fitting the Moderate criteria for low-risk contamination or voluntary precautionary recalls.

Plain-English summary

Genesis Partnership Company SA is recalling 5,040 bottles of Genesis Hand Sanitizer Gel, 1 gallon (3785 mL) bottles. The product is identified by NDC 74484-002-04 and UPC 7401037203427. The specific lot number is 37009, with an expiration date of 02/10/2021.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. The hand sanitizers were manufactured in the same facility as another hand sanitizer product that was found to have sub-potent ethanol levels. This indicates a potential risk that the recalled product may not contain the correct amount of active ingredient.

The product was distributed nationwide in the U.S. Consumers should check their inventory for the specific lot number and expiration date listed above. If the product matches the recalled lot, it should be discarded or returned to the point of purchase.

The recalled product

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.
Manufacturer
Genesis Partnership Company SA
Category
Drug — Hand Sanitizer
Hazard
Affected units
5,040

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot #: 37009
  • Exp. 02/10/2021

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 5 recalled by Genesis Partnership Company SA under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

Related recalls

Same manufacturer · Genesis Partnership Company SA

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Same hazard · sub potent ethanol

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