Class II · Moderate risk
Fluphenazine HCl Elixir
Failed Stability Specifications
LEADER brand Eye Irritation Relief
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
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 Eye Irritation Relief (Polyvinyl alcohol 0.5%, Povidone 0.6%, Tetrahydrozoline Hydrochloride 0.05%), 0.5 FL OZ (15 mL) dropper bottles, Sterile, Distributed By Cardinal Health, Dublin, Ohio 43017, Made in India NDC: 70000-0087-1
Affected NDC
70000-0087-01
Compare with the code on your package — it is the most precise check available.
Drug: Alcohol
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 |
|---|---|---|---|---|
| Eyes Irritation Relief Polyvinyl Alcohol and Povidone and Tetrahydrozoline Hydrochloride NDC 70000-0087 |
POLYVINYL ALCOHOL, UNSPECIFIED 5 mg/mL; POVIDONE, UNSPECIFIED 6 mg/mL; TETRAHYDROZOLINE HYDROCHLORIDE .5 mg/mL | Liquid Ophthalmic |
Cardinal Health 110, LLC. Dba Leader | OTC |
- Recalling firm
- Cardinal Health Inc.
- Origin
- OH, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0131-2024 · 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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