D-1416-2020 Class II Terminated
FDA drug recall D-1416-2020 was initiated by WALKER EMULSIONS INC on June 3, 2020 and is designated Class II. 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. The recall status is terminated (terminated May 13, 2024). Affected quantity: N/A.
Recall Details
- Product Type
- Drugs
- Report Date
- July 29, 2020
- Initiation Date
- June 3, 2020
- Termination Date
- May 13, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
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
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 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).
Code Information
Lot # 209638