Class II · Moderate risk
Fluphenazine HCl Elixir
Failed Stability Specifications
Alcohol Prep Pads
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility and cGMP Deviations
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
Alcohol Prep Pads (Isopropyl Alcohol USP 70% v/v), 100 Individual Pads, Sterile, Distributed by Simple Diagnostics, Winston Park, NY NDC 98302-0001-05
Affected NDC
98302-0001-05
Compare with the code on your package — it is the most precise check available.
Drug: Alcohol
- Recalling firm
- Simple Diagnostics, Inc.
- NDC code
- 98302-0001-05
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0134-2018 · 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
Fluphenazine HCl Elixir
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Class II · Moderate risk
Fluphenazine HCl Elixir
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Class II · Moderate risk
Fluphenazine HCl Elixir
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Class II · Moderate risk
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