Class II · Moderate risk
Fluphenazine HCl Elixir
Failed Stability Specifications
Premium Nature Instant Hand Sanitizer
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Subpotent Drug: FDA analysis has revealed some bottles of these products were sub potent for ethanol.
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
Premium Nature Instant Hand Sanitizer, (ethyl alcohol 65%), plastic bottles packaged as (a) 2 OZ / 60ML, UPC 8 19192 02865 1; (b) 4 OZ, 118 ML, UPC 8 19192 02826 2; (c) 16 OZ, 473 ML, UPC 8 19192 02874 3; (d) 1 gallon, UPC 8 19192 02830 9; Premium Nature, South Plainfield, NJ.
Drug: Alcohol
- Recalling firm
- AMS Packaging Inc
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0646-2022 · 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.
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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 AMS Packaging Inc
All 2022 recalls
Class II · Moderate risk
Premium Nature Instant Hand Sanitizer
Subpotent Drug: FDA analysis has revealed some bottles of these products were sub potent for ethanol.
Class II · Moderate risk
Premium Nature Instant Hand Sanitizer
Subpotent Drug: FDA analysis has revealed some bottles of these products were sub potent for ethanol.
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