FDA recall D-0291-2024

Kilitch Healthcare India Limited · Class I · drug

Product

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

Distribution

Nationwide within the United States

Key facts

Status
Ongoing
Initiation date
2023-11-13
Report date
2024-02-14
Voluntary/Mandated
Voluntary: Firm initiated
Location
Navi Mumbai, India

Primary source

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