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
Reported: November 29, 2023 Initiated: October 31, 2023 #D-0136-2024
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.
Details
- Recalling Firm
- Cardinal Health Inc.
- Units Affected
- 8,784 bottles
- Distribution
- Nationwide in the USA
- Location
- Dublin, OH
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Cardinal Health Inc.. Units affected: 8,784 bottles.
Why was this product recalled? ▼
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 29, 2023. Severity: Critical. Recall number: D-0136-2024.
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