Class II · Moderate risk
Fluphenazine HCl Elixir
Failed Stability Specifications
Hand Sanitizer Disinfectant Gel 70% Ethyl Alcohol
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
cGMP deviations
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 Disinfectant Gel 70% Ethyl Alcohol, packaged in 6.7 FL Oz. (200 mL) bottles, Distributed by: Access USA, Miami, FL 33308, UPC 650240025020
Drug: Alcohol
- Recalling firm
- Resource Recovery & Trading LLC
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- Company announcement
- Jul 27, 2020 · FDA notice with lot numbers
- FDA recall number
- D-1548-2020 · 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 completed, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
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Class II · Moderate risk
HAND SANITIZER Non-sterile Solution 70% Topical Solution
cGMP deviations
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