Class II · Moderate risk
Fluphenazine HCl Elixir
Failed Stability Specifications
blumen ADVANCED INSTANT HAND SANITIZER Clear ETHYL ALCOHOL 70%…
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Chemical Contamination and Subpotent Drug: Product tested to contain methanol as well as below the labeled claim for ethanol content.
Cause type: Wrong potency / content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.
What was recalled
blumen ADVANCED INSTANT HAND SANITIZER Clear ETHYL ALCOHOL 70% natural boost with tea tree oil (70% ethyl alcohol), 33.8 fl oz / 1 L bottle, Distributed in USA and Canada by: 4e Brands 4e Brands Northamerica LLC. 17806 IH-10W, Suite 300, San Antonio, Texas, 78257. Made in Mexico. UPC 8 14266 02374 7
Drug: Alcohol
- Recalling firm
- 4e Brands North America, Llc
- Origin
- TX, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0030-2021 · 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
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 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.
Class II · Moderate risk
ASSURED Instant Hand Sanitizer Aloe & Moisturizers
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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