Fluphenazine HCl Elixir
Failed Stability Specifications
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Incorrect/undeclared excipients: Hand sanitizer was made using the wrong alcohol raw material.
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.
QUIK-CARE Aerosol Foam Hand Sanitizer (62.5% Ethyl Alcohol), packaged in 7 oz cans, Ecolab, 370 Wabasha Street N, St. Paul, MN 55102-1390 USA, NDC 47593-490-82
Compare with the code on your package — it is the most precise check available.
Drug: Alcohol
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Quik-Care Ethyl Alcohol NDC 47593-0490 |
ALCOHOL 54.7 g/100g | Solution Topical |
Ecolab Inc. | OTC |
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Failed Stability Specifications
Failed Stability Specifications
Failed Stability Specifications
Failed Stability Specifications
Failed Stability Specifications
Discoloration and Presence of Foreign Substance
Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.
Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.
Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.
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