Class II · Moderate risk
Fluphenazine HCl Elixir
Failed Stability Specifications
Proton Armor
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Chemical Contamination and CGMP Deviations: trace amounts of methanol found in one of the components during the manufacturing process.
Cause type: Chemical / undeclared
A chemical that should not be there - benzene, methanol, lead - or an undeclared prescription drug hidden in a supplement. The label gives no warning: you may be taking a toxic solvent, a heavy metal, or a drug such as sildenafil that interacts with your other medicines. All chemical / undeclared recalls.
What was recalled
Proton Armor, Anti-Microbial Alcohol-Free Foaming Hand Sanitizer, kills 99.99% of germs, Green Tea and Aloe, Family Safe, No Gels, Water Based, 24 Hour Germ Protection with Moisturizers for Sensitive Skin, a) 8 oz bottle, b) 32 oz bottle, and c) 1.7 fl oz or 50 mL bottle, Supplier details: Ultra Chem Labs, Ontario, CA, Active Ingredients - Benzalkonium Chloride 0.13% (antimicrobial), ULS 8357 0.33% (antimicrobial shield), NDC 79208-001-50.
Affected NDC
79208-0001-50
Compare with the code on your package — it is the most precise check available.
Drug: Alcohol
- Recalling firm
- Ultra Chem Labs Corp
- NDC code
- 79208-001-50
- Origin
- CA, United States
- Initiated by
- N/A
- FDA recall number
- D-0017-2023 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. 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 recalls by Ultra Chem Labs Corp
All 2022 recalls
Class II · Moderate risk
Proton Armor
Chemical Contamination and CGMP Deviations: trace amounts of methanol found in one of the components during the manufacturing process.
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.