Why it was recalled
CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled and found to be subpotent for ethanol and contained methanol.
Product description
IMC Wash-Free Hand Sanitizer, (ethyl alcohol), 75%, 3.4 fl. oz. (100 ml), Made in China, Distributed by IMC 4284 Shoreline Dr, Spring Park, MN 55384. Labeled as a) SAFE-GUARD Products International, b) Safe-WAY JEVCO Wash-Free Hand Sanitizer, c) TRACTION CAPITAL, d) United States Census 2020. UPC 8 19845 00598 5
Lot numbers, UPCs & expiration codes
Lot: MFG: 2020/05/10 L/N: 20200510-3
Where it was sold
Nationwide USA and Canada
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-0240-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 23, 2020
- FDA report date
- Feb 3, 2021
- Quantity
- 42,157 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Shane Erickson Inc
Original FDA data
Every field from FDA enforcement report D-0240-2021, exactly as published.
Show all FDA fields
- City
- Spring Park
- State
- MN
- Status
- Terminated
- Country
- United States
- Event ID
- 87037
- Address
- 4284 Shoreline Dr
- Code information
- Lot: MFG: 2020/05/10 L/N: 20200510-3
- Postal code
- 55384-9652
- Report date
- Feb 3, 2021
- Product type
- Drugs
- Recall number
- D-0240-2021
- Classification
- Class II
- Recalling firm
- Shane Erickson Inc
- Product quantity
- 42,157 bottles
- Termination date
- Sep 29, 2023
- Reason for recall
- CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled and found to be subpotent for ethanol and contained methanol.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- IMC Wash-Free Hand Sanitizer, (ethyl alcohol), 75%, 3.4 fl. oz. (100 ml), Made in China, Distributed by IMC 4284 Shoreline Dr, Spring Park, MN 55384. Labeled as a) SAFE-GUARD Products International, b) Safe-WAY JEVCO Wash-Free Hand Sanitizer, c) TRACTION CAPITAL, d) United States Census 2020. UPC 8 19845 00598 5
- Distribution pattern
- Nationwide USA and Canada
- Recall initiation date
- Dec 23, 2020
- Initial firm notification
- Press Release
- Center classification date
- Jan 22, 2021