Class II · Moderate risk
Fluphenazine HCl Elixir
Failed Stability Specifications
Florance Morris ANTISEPTIC Hand Sanitizer
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Chemical Contamination: FDA analysis found the product contains methanol, additionally it is sub-potent for ethanol content.
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
Florance Morris ANTISEPTIC Hand Sanitizer (ethyl alcohol 70%), packaged in a) 8.45 fl oz (250 mL) bottles and b) 33.81 fl oz (1L) bottles, Distributed by: Asimex International LLC, 9100 S Dadeland Blvd, Ste 912, Miami, FL 33156, COUNTRY OF ORIGIN: MEXICO.
Drug: Alcohol
- Recalling firm
- Grupo Asimex de Mexico SA de CV
- Origin
- N/A, Mexico
- Initiated by
- Voluntary: Firm initiated
- Company announcement
- Aug 17, 2020 · FDA notice with lot numbers
- FDA recall number
- D-0795-2021 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week. 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
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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
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Other recalls by Grupo Asimex de Mexico SA de CV
All 2020 recalls
Class II · Moderate risk
Florance Morris ANTISEPTIC Hand Sanitizer
CGMP Deviations: All other lots are being recalled because they were manufactured under the same conditions as the product lots found to contain methanol.
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