Walker Emulsions Hand Sanitizer recalled over undeclared excipients

Recall date

June 3, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

WALKER EMULSIONS INC recalls Walker Emulsions Hand Sanitizer (60%), Non-Sterile Solution, Alcohol Antiseptic 60%, 1 Gallon, Topical Solution, Walker…

Recall number

D-1416-2020

FDA classification

Class II

Brand / firm

WALKER EMULSIONS INC

Sold / distributed

US Distribution: Product distributed to sister plant site located in SC, and one donation made to consignee located in OR. Majority of hand sanitizer shipped to Canada (Health Canada has already received consignee information and classified the recall).

Why it was recalled

Incorrect/Undeclared Excipients: Notification received from Health Canada that DA-2I Ethanol is a type not an approved for use in Hand Sanitizer.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Walker Emulsions Hand Sanitizer (60%), Non-Sterile Solution, Alcohol Antiseptic 60%, 1 Gallon, Topical Solution, Walker Emulsions Inc., 4401 SE Johnson Creek Blvd., Portland, OR 97222, NDC 74940-0415-1