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Recall Observatory FDA recall evidence

Drug 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

D-0033-2021

August 14, 2020

Class I

Product summary

Firm
Volu-Sol, Inc.
Event
Event 86428
Status
Terminated
Classification
Class I
Quantity
N/A
Official record key
drug-enforcement:D-0033-2021

Official wording

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

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

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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