Genesis Hand Sanitizer Gel Recalled for CGMP Deviations
Genesis Partnership Company SA is recalling 15,000 bottles of Genesis 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 reasonable probability of temporary or medically reversible health consequences. The hazard is a CGMP deviation regarding potential sub-potency, which is a lower risk than confirmed contamination or serious injury.
Plain-English summary
Genesis Partnership Company SA is recalling 15,000 bottles of Genesis Hand Sanitizer Gel, 240 mL (8 FL OZ.) bottles. The product is identified by NDC 74484-002-02 and UPC 7401037205773. 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 required amount of active ingredient.
The product was distributed nationwide in the U.S. Consumers who have this product should stop using it and contact the recalling firm for further instructions or a refund.
The recalled product
- 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.
- Manufacturer
- Genesis Partnership Company SA
- Category
- Drug — Hand Sanitizer
- Affected units
- 15,000
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
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