Class I
Ongoing
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
This recall is currently active, issued November 29, 2023. It was issued by Cardinal Health Inc..
- Company
- Cardinal Health Inc.
- Recall Initiated
- October 31, 2023
- Posted
- November 29, 2023
- Recall Number
- D-0136-2024
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 8,784 bottles
- Firm Location
- Dublin, OH, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Distribution
Nationwide in the USA
Lot / Code Info
ALL LOTS
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