Class II · Moderate risk
Fluphenazine HCl Elixir
Failed Stability Specifications
blumen Clear ADVANCED HAND SANITIZER with 70% ALCOHOL
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: recalled because it was manufactured in the same facility as the product found to contain methanol which represents poor Current Good Manufacturing Practices.
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
blumen Clear ADVANCED HAND SANITIZER with 70% ALCOHOL, (ethyl alcohol 70% v/v), Packaged as a) 2 fl oz / 60 ml bottle, UPC 8 14266 02371 6 b) 7.5 fl oz / 221 ml bottle, UPC 8 14266 02362 4 c) 15.2 fl oz (450 ml) bottle, UPC 8 14266 02392 1, d) 17 fl oz / 503 ml bottle with blue cap or pump bottle, UPC 8 14266 02409 6, e) 18 fl oz / 532 ml bottle, UPC 8 14266 02391 4, f) 33.8 fl oz / 1 L straight or curved bottle, UPC 8 14266 02369 3 g) 70 fl oz / 2.07L bottle, UPC 8 14266 02367 9 h) 1.05 GAL / 4L bottle, UPC 8 14266 02368 6; Distributed in USA and Canada By: 4e Brands Northamerica LLC, 17806 IH-10W, Suite 300, San Antonio, Texas, 78257, Made in Mexico.
Drug: Alcohol
- Recalling firm
- 4e Brands North America, Llc
- Origin
- TX, United States
- Initiated by
- Voluntary: Firm initiated
- Company announcement
- Jul 11, 2020 · FDA notice with lot numbers
- FDA recall number
- D-0024-2021 · 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.
Other Alcohol recalls
See all
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
Failed Stability Specifications
Other recalls by 4e Brands North America, Llc
All 2020 recalls
Class I · High risk
blumen ADVANCED HAND SANITIZER 70% ALCOHOL CONTENT
Chemical Contamination and Subpotent Drug: Product tested to contain methanol as well as below the labeled claim for ethanol content.
Class I · High risk
blumen ADVANCED INSTANT HAND SANITIZER Clear ETHYL ALCOHOL 70%…
Chemical Contamination and Subpotent Drug: Product tested to contain methanol as well as below the labeled claim for ethanol content.
Class I · High risk
blumen Clear ADVANCED HAND SANITIZER with 70% ALCOHOL
Chemical Contamination and Subpotent Drug: Product tested to contain methanol as well as below the labeled claim for ethanol content.
Class II · Moderate risk
Modesa instant HAND SANITIZER with moisturizers & vitamin E
CGMP Deviations: recalled because it was manufactured in the same facility as the product found to contain methanol which represents poor Current Good Manufacturing Practices.
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