Class II · Moderate risk
Fluphenazine HCl Elixir
Failed Stability Specifications
Polyvinyl Alcohol Ophthalmic Solution 1.4%
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
LABELING: LABEL MIX-UP
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
What was recalled
Polyvinyl Alcohol Ophthalmic Solution 1.4%, Moisturizing Lubricant Eye Drops, 0.5 FL OZ (15 mL) bottles, Distributed by AvKARE, Pulaski, TN 38478, www.avkare.com, 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
- AvKARE
- NDC code
- 50268-678-15
- Origin
- TN, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0176-2025 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm.
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