Class II · Moderate risk
Fluphenazine HCl Elixir
Failed Stability Specifications
Polyvinyl Alcohol Ophthalmic Solution 1.4%
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
cGMP deviations and lack of assurance of sterility.
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
Polyvinyl Alcohol Ophthalmic Solution 1.4%, Lubricant Eye Drops, Moisturizing, Sterile, 0.5 FL OZ (15mL) per dropper bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-678-15.
Affected NDC
50268-0678-15
Compare with the code on your package — it is the most precise check available.
Drug: Alcohol Category: Eye Drops & Ophthalmic
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Polyvinyl Alcohol NDC 50268-0678 |
14 mg/mL | Solution/ Drops Ophthalmic |
AvPAK | OTC |
- Recalling firm
- BRS Analytical Services, LLC
- Origin
- MO, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0408-2025 · 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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cGMP deviations and lack of assurance of sterility.
Class II · Moderate risk
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