Recalls / Class I
Class ID-0299-2024
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 (Carboxymethylcellulose Sodium 1%), packaged in 0.5 FL OZ (15 mL) bottles, Cardinal Health Dublin, Ohio 43017, NDC 70000-0089-1
- Brand name
- Dry Eye Relief
- Generic name
- Carboxymethylcellulose Sodium
- Active ingredient
- Carboxymethylcellulose Sodium, Unspecified
- Route
- Ophthalmic
- NDC
- 70000-0089
- FDA application
- M018
- Affected lot / code info
- All lots
Why it was recalled
Non-Sterility
Recalling firm
- Firm
- Kilitch Healthcare India Limited
- Manufacturer
- CARDINAL HEALTH 110, LLC. DBA LEADER
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- R - 904 905 T T C Industrial Road, Navi Mumbai, N/A, India
Distribution
- Quantity
- 23,208 bottles
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2023-11-13
- FDA classified
- 2024-02-05
- Posted by FDA
- 2024-02-14
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0299-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.