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
Reported: October 7, 2020 Initiated: August 14, 2020 #D-0033-2021
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.
Details
- Recalling Firm
- Volu-Sol, Inc.
- Units Affected
- N/A
- Distribution
- Sold to one distributor located in CA and one hospital system located in UT.
- Location
- Salt Lake City, UT
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Volu-Sol, Inc.. Units affected: N/A.
Why was this product recalled? ▼
Marketed Without an Approved NDA/ANDA: product lists methanol as an inactive ingredient on the label.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 7, 2020. Severity: Critical. Recall number: D-0033-2021.
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