Class II · Moderate risk
Fluphenazine HCl Elixir
Failed Stability Specifications
V-Klean Hand Sanitizer Gel Alcohol 70% packaged as a)8.5 fl oz
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of CGMPs:
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
V-Klean Hand Sanitizer Gel Alcohol 70% packaged as a)8.5 fl oz (250 ml), UPC 7 16053 70499 3; b) 16.9 fl oz (500 ml), UPC 7 16053 70499 3; c) 33.8 fl. oz. (1000 ml) bottles: 716053704993; Manufactured by: Asiaticon S.A. de C.V. Conkar 62, Jardines del Ajusco. Tlalpan Cuidad de Mexico. 14200 ;
Drug: Alcohol
- Recalling firm
- Asiaticon, SA de CV
- Origin
- N/A, Mexico
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0116-2021 · 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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Class II · Moderate risk
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Class II · Moderate risk
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Lack of CGMPs:
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