Volu-Sol Handrub Sanitizing Solution Recalled for Unapproved Marketing
Volu-Sol, Inc. is recalling handrub sanitizing solution marketed without an approved NDA/ANDA and listing methanol as an inactive ingredient.
The agency’s classification
FDA (Drugs): Class I
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric. The presence of methanol as an inactive ingredient in a topical product also represents a significant safety hazard.
Plain-English summary
Volu-Sol, Inc. is recalling 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. The product is identified by NDC 74401-800-16. The recall involves specific lots: WHO100, WHO101 (Exp. Date 4/2022) and WHO104, WHO105, WHO108, WHO109 (Exp. Date 05/2022).
The recall was initiated because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). Additionally, the product label lists methanol as an inactive ingredient. Methanol is a toxic substance that can cause serious health effects if ingested or absorbed in significant quantities, though the source text does not report specific illnesses or injuries.
The affected product was sold to one distributor located in California and one hospital system located in Utah. Consumers and healthcare facilities should stop using the product and contact the recalling firm or their supplier for instructions on return or disposal.
The recalled product
- 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
- Manufacturer
- Volu-Sol, Inc.
- Category
- Drug — Topical Antiseptic
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- Lot #: WHO100
- WHO101
- Exp. Date 4/2022
- WHO104
- WHO105
- WHO108
- WHO109
- Exp. Date 05/2022
Distribution
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