Class II · Moderate risk
Fluphenazine HCl Elixir
Failed Stability Specifications
HAND SANITIZER SAY GOODBYE TO GERMS Alcohol Antiseptic 80% Topical Non-Sterile Solution
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
HAND SANITIZER SAY GOODBYE TO GERMS Alcohol Antiseptic 80% Topical Non-Sterile Solution, 12 FL OZ (254 mL) bottles, Distributed by: Hand Cleansing Gel 850 Kaliste Saloom Rd. Suite 212 Lafayette, LA 70508 UPC 8 60003 62626 9
Drug: Alcohol
- Recalling firm
- Hand Sanitizer LLC
- Origin
- LA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1149-2022 · 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.
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