Class II · Moderate risk
Fluphenazine HCl Elixir
Failed Stability Specifications
Rugby brand Polyvinyl Alcohol 1.4% Lubricating Eye Drops
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Non-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
Rugby brand Polyvinyl Alcohol 1.4% Lubricating Eye Drops, packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: Rugby Laboratories, Livonia, MI 48152, NDC 0536-1325-94
Affected NDC
0536-1325-94
Compare with the code on your package — it is the most precise check available.
Drug: Alcohol Category: Eye Drops & Ophthalmic
- Recalling firm
- Kilitch Healthcare India Limited
- NDC code
- 0536-1325-94
- Origin
- India
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0293-2024 · 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.
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