FDA-Drug2020-10-07Class I

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

Volu-Sol, Inc.
Hazard

Marketed Without an Approved NDA/ANDA: product lists methanol as an inactive ingredient on the label.

Sold states
Sold to one distributor located in CA and one hospital system located in UT.
Affected count
N/A
Manufactured in
5095 W 2100 S, N/A, Salt Lake City, UT, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0033-2021

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