Class I · High risk
Up&Up brand dry eye relief
Non-Sterility
Rugby brand Lubricating Tears 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 Lubricating Tears Eye Drops (Dextran 70 0.1%, Hypromellose 2910 0.3%), packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: Rugby Laboratories, Livonia, MI 48152, NDC 0536-1282-94
Affected NDC
0536-1282-94
Compare with the code on your package — it is the most precise check available.
Category: Eye Drops & Ophthalmic
- Recalling firm
- Kilitch Healthcare India Limited
- NDC code
- 0536-1282-94
- Origin
- India
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0310-2024 · 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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Class I · High risk
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Other sterility / contamination recalls from 2023
All sterility / contamination recalls
Class II · Moderate risk
DELFLEX Peritoneal Dialysis Solution in Biofine container 1.5% Dextrose
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Class II · Moderate risk
ceFAZolin sodium in Sterile Water for injection
Lack of assurance of sterility.
Class I · High risk
Up&Up brand dry eye relief
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Class I · High risk
Lubricant Eye Drops
Non-Sterility
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