Recalls / Class I
Class ID-0131-2024
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
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
- Brand name
- Eyes Irritation Relief
- Generic name
- Polyvinyl Alcohol And Povidone And Tetrahydrozoline Hydrochloride
- Active ingredients
- Polyvinyl Alcohol, Unspecified, Povidone, Unspecified, Tetrahydrozoline Hydrochloride
- Route
- Ophthalmic
- NDC
- 70000-0087
- FDA application
- M018
- Affected lot / code info
- ALL LOTS
Why it was recalled
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Recalling firm
- Firm
- Cardinal Health Inc.
- Manufacturer
- CARDINAL HEALTH 110, LLC. DBA LEADER
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 7000 Cardinal Pl, N/A, Dublin, Ohio 43017-1091
Distribution
- Quantity
- 11629 units
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2023-10-31
- FDA classified
- 2023-12-01
- Posted by FDA
- 2023-11-29
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0131-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.