Class I · High risk
Up&Up brand dry eye relief
Non-Sterility
Leader brand Dry Eye Relief (Polyethylene Glycol and Propylene Glycol)
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
Leader brand Dry Eye Relief (Polyethylene glycol 400 0.4% and Propylene glycol 0.3%) packaged in 0.33 FL OZ (10 mL) bottles, Distributed by Cardinal Health Dublin, Ohio 43017, NDC 70000-0088-1
Affected NDC
70000-0088-01
Compare with the code on your package — it is the most precise check available.
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 |
|---|---|---|---|---|
| Dry eye relief polyethylene glycol and propylene glycol NDC 70000-0088 |
POLYETHYLENE GLYCOL 400 4 mg/mL; PROPYLENE GLYCOL 3 mg/mL | Gel Ophthalmic |
Cardinal Health 110, LLC. Dba Leader | OTC |
- Recalling firm
- Kilitch Healthcare India Limited
- NDC code
- 70000-0088-1
- Origin
- India
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0295-2024 · 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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Rugby brand Lubricating Tears Eye Drops
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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
Non-Sterility
Class I · High risk
Rugby brand Lubricating Tears Eye Drops
Non-Sterility
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