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.
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
Lot numbers, UPCs & expiration codes
Lot # 209638
Where it was sold
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).
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1416-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 3, 2020
- FDA report date
- Jul 29, 2020
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- WALKER EMULSIONS INC
Original FDA data
Every field from FDA enforcement report D-1416-2020, exactly as published.
Show all FDA fields
- City
- Portland
- State
- OR
- Status
- Terminated
- Country
- United States
- Event ID
- 85955
- Address
- 4401 Se Johnson Creek Blvd
- Code information
- Lot # 209638
- Postal code
- 97222-9218
- Report date
- Jul 29, 2020
- Product type
- Drugs
- Recall number
- D-1416-2020
- Classification
- Class II
- Recalling firm
- WALKER EMULSIONS INC
- Termination date
- May 13, 2024
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- 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).
- Recall initiation date
- Jun 3, 2020
- Initial firm notification
- Letter
- Center classification date
- Jul 28, 2020