FDA Recall D-0033-2021

Volu-Sol, Inc. · Salt Lake City, UT

Class I — life-threatening Terminated 1291 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.

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

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

Quantity: N/A

Reason for recall

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

Recall record

Recall number: D-0033-2021
Classification: Class I
Status: Terminated
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Telephone
Distribution: Sold to one distributor located in CA and one hospital system located in UT.
Recall initiated: 2020-08-14
Classified by FDA Center: 2020-10-14
FDA published: 2020-10-07
Terminated: 2024-02-26
Recalling firm: Volu-Sol, Inc.
Firm location: Salt Lake City, UT

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