FDA-Drug2024-02-14Class I

Leader brand Lubricant Eye Drops (Carboxymethylcellulose Sodium 0.5%), packaged in a) 0.5 FL OZ (15mL) bottles (Single Pack) (NDC 70000-0090-1) and b) 0.5 FL OZ (15 mL) bottles (Twin pack) (NDC 70000-0090-2), Distributed by: Cardinal Health Dublin, Ohio 43017

Kilitch Healthcare India Limited
Hazard

Non-Sterility

Sold states
Nationwide within the United States
Affected count
210,192 bottles
Manufactured in
R - 904 905 T T C Industrial Road, Navi Mumbai, India
Products
Leader brand Lubricant Eye Drops (Carboxymethylcellulose Sodium 0.5%), packaged in a) 0.5 FL OZ (15mL) bottles (Single Pack) (NDC 70000-0090-1) and b) 0.5 FL OZ (15 mL) bottles (Twin pack) (NDC 70000-0090-2), Distributed by: Cardinal Health Dublin, Ohio 43017

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0291-2024

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