Home / Recalls / Volu-Sol, Inc. / D-0033-2021

D-0033-2021 Class I Terminated

Recalled by Volu-Sol, Inc. — Salt Lake City, UT

Recall Details

Product Type: Drugs
Report Date: October 7, 2020
Initiation Date: August 14, 2020
Termination Date: February 26, 2024
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: N/A

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.

Distribution Pattern

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

Code Information

Lot #: WHO100, WHO101, Exp. Date 4/2022; WHO104, WHO105, WHO108, WHO109, Exp. Date 05/2022