Volu-Sol, Inc. recalls Volu-Sol Handrub Sanitizing Solution (Ethyl Alcohol, 69% v/v and Isopropyl Alcohol, 7.2% v/v) Topical Solution, 473 mL/…

Recall date

August 14, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0033-2021

FDA classification

Class I

Brand / firm

Volu-Sol, Inc.

Sold / distributed

Sold to one distributor located in CA and one hospital system located in UT.

Why it was recalled

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

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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