D-0136-2024 Class I Ongoing
FDA drug recall D-0136-2024 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: 8,784 bottles.
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
- 8,784 bottles
Product Description
LEADER brand Lubricant Eye Drops (Propylene Glycol, 0.6%); 0.33 FL OZ (10 mL) dropper bottles, Sterile, Distributed By Cardinal Health, Dublin, Ohio 43017. Made in India NDC: 70000-0587-1
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