FDA-Drug2023-11-29Class I
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
Cardinal Health Inc.
Hazard
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Sold states
Nationwide in the USA
Affected count
8,784 bottles
Manufactured in
7000 Cardinal Pl, N/A, Dublin, OH, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0136-2024Don't want to check this manually?
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