Why it was recalled
Marketed Without an Approved NDA/ANDA: product lists methanol as an inactive ingredient on the label.
Product description
Volu-Sol Handrub Sanitizing Solution (Ethyl Alcohol, 69% v/v and Isopropyl Alcohol, 7.2% v/v) Topical Solution, 473 mL/ 16 fl oz bottle, Vou-Sol 5095 W 2100 S, Salt Lake City, UT 84120, NDC 74401-800-16
Lot numbers, UPCs & expiration codes
Lot #: WHO100, WHO101, Exp. Date 4/2022; WHO104, WHO105, WHO108, WHO109, Exp. Date 05/2022
Where it was sold
Sold to one distributor located in CA and one hospital system located in UT.
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-0033-2021
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Aug 14, 2020
- FDA report date
- Oct 7, 2020
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Volu-Sol, Inc.
Original FDA data
Every field from FDA enforcement report D-0033-2021, exactly as published.
Show all FDA fields
- City
- Salt Lake City
- State
- UT
- Status
- Terminated
- Country
- United States
- Event ID
- 86428
- Address
- 5095 W 2100 S
- Code information
- Lot #: WHO100, WHO101, Exp. Date 4/2022; WHO104, WHO105, WHO108, WHO109, Exp. Date 05/2022
- Postal code
- 84120-1229
- Report date
- Oct 7, 2020
- Product type
- Drugs
- Recall number
- D-0033-2021
- Classification
- Class I
- Recalling firm
- Volu-Sol, Inc.
- Termination date
- Feb 26, 2024
- Reason for recall
- Marketed Without an Approved NDA/ANDA: product lists methanol as an inactive ingredient on the label.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Volu-Sol Handrub Sanitizing Solution (Ethyl Alcohol, 69% v/v and Isopropyl Alcohol, 7.2% v/v) Topical Solution, 473 mL/ 16 fl oz bottle, Vou-Sol 5095 W 2100 S, Salt Lake City, UT 84120, NDC 74401-800-16
- Distribution pattern
- Sold to one distributor located in CA and one hospital system located in UT.
- Recall initiation date
- Aug 14, 2020
- Initial firm notification
- Telephone
- Center classification date
- Oct 14, 2020