LEADER brand Dry Eye Relief (Polyethylene Glycol 400, 0
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
- Agency
- FDA Drug
- Recall date
- Oct 31, 2023
- Status
- Ongoing
- Company
- Cardinal Health Inc.
1. What product was recalled?
LEADER brand Dry Eye Relief (Polyethylene Glycol 400, 0
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
Quantity: 11,782 bottles
Code or lot text: ALL LOTS
- LOT
- ALL LOTS
- NDC
- 70000-0088
- NDC
- 70000-0088-1
- RECALL-NUMBER
- D-0135-2024
LEADER brand Eye Irritation Relief (Polyvinyl alcohol 0
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
Quantity: 11629 units
Code or lot text: ALL LOTS
- LOT
- ALL LOTS
- NDC
- 70000-0087
- NDC
- 70000-0087-1
- RECALL-NUMBER
- D-0131-2024
LEADER brand Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0
LEADER brand Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%); 2 bottles, 0.5 FL OZ (15 mL) dropper bottles, Sterile, Distributed By Cardinal Health, Dublin, Ohio 43017, Made in India NDC:70000-0090-2 (Carton); 70000-0090-1 (Bottle)
Quantity: 28477 cartons
Code or lot text: ALL LOTS
- LOT
- ALL LOTS
- NDC
- 70000-0090
- NDC
- 70000-0090-1
- NDC
- 70000-0090-2
- RECALL-NUMBER
- D-0134-2024
2. Is my exact product affected?
Compare every printed identifier. A matching value can indicate that your product is included.
3. What is the hazard?
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
4. What should I do now?
Follow the FDA recall notice and contact the recalling company for current instructions.
5. Where was it sold or distributed?
Nationwide
6. Were injuries or illnesses reported?
No separate injury or illness statement was present in the normalized record. Check the official source for the latest report.
7. What remedy is available?
Follow the FDA recall notice and contact the recalling company for current instructions.
8. Is the recall active or closed?
The source status is Ongoing. Recall Index urgency is urgent, which is a separate deterministic site label.
9. When was the information checked?
Last checked .
- created
10. Where is the official source?
Open the official FDA Drug source
Recall Index normalizes public source data for easier checking. Source agencies remain authoritative. Confirm identifiers and instructions at the official source.