The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0037-2021·Announced 2020-10-28

Panagel Hand Sanitizer Recalled for CGMP Deviations and Sub-Potent Ethanol Risk

Genesis Partnership Company SA is recalling 33,480 bottles of Panagel Hand Sanitizer due to CGMP deviations and potential sub-potent ethanol levels.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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 due to CGMP deviations and potential sub-potent ethanol levels, which fits the rubric for moderate severity involving low-risk contamination or voluntary precautionary measures without reported illness.

Plain-English summary

Genesis Partnership Company SA is recalling 33,480 bottles of Panagel Hand Sanitizer, 70% Alcohol, 16 Fl. Oz. (472 mL) bottles. The product was distributed nationwide in the U.S. by Central Med Distribution. The specific lot number is 072120, with an expiration date of 01/21/2022.

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 had sub-potent ethanol levels. This shared facility use raises concerns about the quality and potency of the recalled product.

Consumers who have purchased this product should stop using it and contact the distributor or manufacturer for further instructions. The FDA has classified this recall as Class II, indicating a reasonable probability that use of the product may cause temporary or medically reversible adverse health consequences.

The recalled product

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.
Manufacturer
Genesis Partnership Company SA
Category
Drug — Hand Sanitizer
Hazard
Affected units
33,480

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 #: 072120
  • Exp. 01/21/2022

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 →

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