Drug product
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
D-0033-2021
Product summary
- Firm
- Volu-Sol, Inc.
- Event
- Event 86428
- Status
- Terminated
- Classification
- Class I
- Quantity
- N/A
- Official record key
drug-enforcement:D-0033-2021
Official wording
Reason: Marketed Without an Approved NDA/ANDA: product lists methanol as an inactive ingredient on the label.
Code information: Lot #: WHO100, WHO101, Exp. Date 4/2022; WHO104, WHO105, WHO108, WHO109, Exp. Date 05/2022
Distribution pattern: Sold to one distributor located in CA and one hospital system located in UT.
Derived failure modes
-
Unknown
Marketed Without an Approved NDA/ANDA: product lists methanol as an inactive ingredient on the label.