Recalls / Class I
Class ID-0135-2024
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 Dry Eye Relief (Polyethylene Glycol 400, 0.4% Propylene Glycol, 0.3%); 0.33 FL OZ (10 mL) dropper bottle, Sterile, Distributed By Cardinal Health, Dublin, Ohio 43017, Made in India NDC: 70000-0088-1
- Brand name
- Dry Eye Relief
- Generic name
- Polyethylene Glycol And Propylene Glycol
- Active ingredients
- Polyethylene Glycol 400, Propylene Glycol
- Route
- Ophthalmic
- NDC
- 70000-0088
- 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
- 11,782 bottles
- 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-0135-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.