Class II · Moderate risk
Folic Acid
Lack of sterility assurance.
puriton EYE RELIEF DROPS
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Non-Sterility: Product manufactured under non-sterile production conditions.
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
puriton EYE RELIEF DROPS, 0.5 oz (15 ml) bottle, Kadesh Inc., NDC#7079600115, UPC 7 36972 16799 0.
Affected NDC
70796-0011-05
Compare with the code on your package — it is the most precise check available.
- Recalling firm
- Kadesh International
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0250-2019 · 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. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other sterility / contamination recalls from 2018
All sterility / contamination recalls
Class II · Moderate risk
Zinc Sulfate
Lack of sterility assurance.
Class II · Moderate risk
Glycyrrhizic Acid
Lack of sterility assurance.
Class II · Moderate risk
Dexpanthenol
Lack of sterility assurance.
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