FDA Recall D-0040-2021

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

Killz Germz Hand Sanitizer, Alcohol Gel, 450 mL (15 fl oz.) bottle, Manufactured by Genesis Partnership Company S.A., Guatemala, For: Killz Germz, LLC., 1912 R street NW, Washington DC, 20009, NDC 74625-003-04, UPC 7401037203250.

Lot / code: Lot #s: 36748, 36818, 36697, Exp. 10/15/21 and 11/8/21

Quantity: 5,320 bottles

Reason for recall

Sub-Potent Drug; Killz GERMz was recalled due to sub-potent results. Testing revealed ethanol levels as low as 62% while labelled claim is 70%.

Recall record

Recall number: D-0040-2021
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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