PlainRecalls
FDA Drug Critical Class I Terminated

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

Reported: October 7, 2020 Initiated: August 14, 2020 #D-0033-2021

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

Reason for Recall

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

Details

Recalling Firm
Volu-Sol, Inc.
Units Affected
N/A
Distribution
Sold to one distributor located in CA and one hospital system located in UT.
Location
Salt Lake City, UT

Frequently Asked Questions

What product 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. Recalled by Volu-Sol, Inc.. Units affected: N/A.
Why was this product recalled?
Marketed Without an Approved NDA/ANDA: product lists methanol as an inactive ingredient on the label.
Which agency issued this recall?
This recall was issued by the FDA Drug on October 7, 2020. Severity: Critical. Recall number: D-0033-2021.