August 2020 FDA Recall Drug by Volu-sol, Inc.
D-0033-2021 - Marketed Without an Approved NDA/ANDA

This Class I drug recall was voluntarily initiated by Volu-sol, Inc. on August 14, 2020 for the product Drug. The FDA reported the reason for recall as marketed without an approved nda/anda. The product was distributed in Sold to one distributor located in CA and one hospital system located in UT. and the recall is currently terminated.

Recall Number: D-0033-2021

Reason for Recall
Marketed Without an Approved NDA/ANDA: product lists methanol as an inactive ingredient on the label.
Initiated
08-14-2020
Reported
10-07-2020
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86428
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Volu-Sol, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Sold to one distributor located in CA and one hospital system located in UT.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-26-2024
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

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