Class II · Moderate risk
Fluphenazine HCl Elixir
Failed Stability Specifications
Volu-Sol Handrub Sanitizing Solution
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Marketed Without an Approved NDA/ANDA: product lists methanol as an inactive ingredient on the label.
Cause type: Unapproved drug
The product was marketed without an approved NDA/ANDA, or does not meet the OTC monograph it claims to follow. Nothing about the product - dose, purity, safety - has been reviewed by FDA, so the claims on the box are unverified. All unapproved drug recalls.
What 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
Affected NDC
74401-0800-16
Compare with the code on your package — it is the most precise check available.
Drug: Alcohol
- Recalling firm
- Volu-Sol, Inc.
- NDC code
- 74401-800-16
- Origin
- UT, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0033-2021 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Alcohol recalls
See all
Class II · Moderate risk
Fluphenazine HCl Elixir
Failed Stability Specifications
Class II · Moderate risk
Fluphenazine HCl Elixir
Failed Stability Specifications
Class II · Moderate risk
Fluphenazine HCl Elixir
Failed Stability Specifications
Class II · Moderate risk
Fluphenazine HCl Elixir
Failed Stability Specifications
Other unapproved drug recalls from 2020
All unapproved drug recalls
Class II · Moderate risk
Immune Boost with natural strawberry flavor
Marketed without an Approved NDA/ANDA: Product marketed with drug claims.
Class I · High risk
Leafree Instant Hand Sanitizer Aloe Vera
Marketed without an Approved NDA/ANDA; product labeled as Edible Alcohol rendering the product an unapproved new drug and misbranded.
Class II · Moderate risk
pH-D Feminine Health Boric Acid Vaginal Suppositories
Marketed without an Approved NDA/ANDA.
Class II · Moderate risk
Thyro-H
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
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