D-0134-2024 Class I Ongoing
FDA drug recall D-0134-2024 was initiated by Cardinal Health Inc. on October 31, 2023 and is designated Class I. Reason for recall: Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility. The recall status is ongoing. Affected quantity: 28477 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- November 29, 2023
- Initiation Date
- October 31, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 28477 cartons
Product Description
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)
Reason for Recall
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Distribution Pattern
Nationwide in the USA
Code Information
ALL LOTS