Why it was recalled
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Product description
LEADER brand Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%); 0.5 FL OZ (15 mL) dropper bottles, Sterile, Distributed By Cardinal Health, Dublin, Ohio 43017. Made in India NDC: 70000-0090-1
Lot numbers, UPCs & expiration codes
ALL LOTS
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0133-2024
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- Oct 31, 2023
- FDA report date
- Nov 29, 2023
- Quantity
- 119,871 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Cardinal Health Inc.
Original FDA data
Every field from FDA enforcement report D-0133-2024, exactly as published.
Show all FDA fields
- City
- Dublin
- State
- OH
- Status
- Ongoing
- Country
- United States
- Event ID
- 93346
- Address
- 7000 Cardinal Pl
- Code information
- ALL LOTS
- Postal code
- 43017-1091
- Report date
- Nov 29, 2023
- Product type
- Drugs
- Recall number
- D-0133-2024
- Classification
- Class I
- Recalling firm
- Cardinal Health Inc.
- Product quantity
- 119,871 bottles
- Reason for recall
- Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- LEADER brand Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%); 0.5 FL OZ (15 mL) dropper bottles, Sterile, Distributed By Cardinal Health, Dublin, Ohio 43017. Made in India NDC: 70000-0090-1
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Oct 31, 2023
- Initial firm notification
- Press Release
- Center classification date
- Dec 1, 2023