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
FDA recall notice · announced October 7, 2020 · Volu-sol
Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.
The 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
Reason for recall
Marketed Without an Approved NDA/ANDA: product lists methanol as an inactive ingredient on the label.
Notes
Distribution: Sold to one distributor located in CA and one hospital system located in UT.
Lot/code information: Lot #: WHO100, WHO101, Exp. Date 4/2022; WHO104, WHO105, WHO108, WHO109, Exp. Date 05/2022
Quantity: N/A
Status: Terminated
Products in this recall event:
- 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- (D-0033-2021)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.