FDA Recall D-0039-2021

Genesis Partnership Company SA · Villa Nueva, N/A

Class II Ongoing 2071 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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.

Lot / code: Lot #: 37009, Exp. 02/10/2021

Quantity: 5,040 bottles

Reason for recall

CGMP Deviations: hand sanitizers were recalled because they were manufactured in the same facility as another hand sanitizer product with sub-potent ethanol levels.

Recall record

Recall number: D-0039-2021
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the U.S.
Recall initiated: 2020-09-11
Classified by FDA Center: 2020-10-19
FDA published: 2020-10-28
Recalling firm: Genesis Partnership Company SA
Firm location: Villa Nueva, N/A, Guatemala

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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