FDA recall D-0301-2024

Kilitch Healthcare India Limited · Class I · drug

Product

Leader brand Lubricant Eye Drops (Propylene glycol Eye Drops 0.6%), packaged in 0.33 FL OZ (10 mL) bottles, Cardinal Health Dublin, Ohio 43017, NDC 70000-0587-1

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-0301-2024