FDA recall D-0033-2021

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.

Distribution

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

Key facts

Status

Terminated

Initiation date

2020-08-14

Report date

2020-10-07

Termination date

2024-02-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Salt Lake City, UT, United States

Primary source

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