PlainRecalls
FDA Drug Critical Class I Ongoing

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

Reported: February 14, 2024 Initiated: November 13, 2023 #D-0291-2024

Product Description

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

Reason for Recall

Non-Sterility

Details

Units Affected
210,192 bottles
Distribution
Nationwide within the United States
Location
Navi Mumbai

Frequently Asked Questions

What product was recalled?
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. Recalled by Kilitch Healthcare India Limited. Units affected: 210,192 bottles.
Why was this product recalled?
Non-Sterility
Which agency issued this recall?
This recall was issued by the FDA Drug on February 14, 2024. Severity: Critical. Recall number: D-0291-2024.