Drug product
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
D-1416-2020
Product summary
- Event
- Event 85955
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-1416-2020
Official wording
Reason: Incorrect/Undeclared Excipients: Notification received from Health Canada that DA-2I Ethanol is a type not an approved for use in Hand Sanitizer.
Code information: Lot # 209638
Distribution pattern: 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).
Derived failure modes
-
Unknown
Incorrect/Undeclared Excipients: Notification received from Health Canada that DA-2I Ethanol is a type not an approved for use in Hand Sanitizer.