FDA-Drug2023-11-29Class I

LEADER brand Dry Eye Relief (Carboxymethylcellulose Sodium, 1%); 0.5 FL OZ (15 mL) dropper bottle, Sterile, Distributed By Cardinal Health, Dublin, Ohio. 43017, Made in India NDC: 70000-0089-1

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
21,802 bottles
Manufactured in
7000 Cardinal Pl, N/A, Dublin, OH, United States
Products
LEADER brand Dry Eye Relief (Carboxymethylcellulose Sodium, 1%); 0.5 FL OZ (15 mL) dropper bottle, Sterile, Distributed By Cardinal Health, Dublin, Ohio. 43017, Made in India NDC: 70000-0089-1

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0132-2024

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