FDA recall D-0295-2024

Kilitch Healthcare India Limited · Class I · drug

Product

Leader brand Dry Eye Relief (Polyethylene glycol 400 0.4% and Propylene glycol 0.3%) packaged in 0.33 FL OZ (10 mL) bottles, Distributed by Cardinal Health Dublin, Ohio 43017, NDC 70000-0088-1

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-0295-2024