FDA recall D-1417-2020

WALKER EMULSIONS INC · Class II · drug

Product

Walker Hand Sanitizer, Non-Sterile Solution, Alcohol Antiseptic, 70%, 32 oz and 16 oz, Topical Solution, Walker Emulsions Inc., 4401 SE Johnson Creek Blvd., Portland, OR 97222, NDC 74940-0415-1

Reason for recall

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

Distribution

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).

Key facts

Status
Terminated
Initiation date
2020-06-03
Report date
2020-07-29
Termination date
2024-05-13
Voluntary/Mandated
Voluntary: Firm initiated
Location
Portland, OR, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1417-2020