FDA recall D-0293-2024

Kilitch Healthcare India Limited · Class I · drug

Product

Rugby brand Polyvinyl Alcohol 1.4% Lubricating Eye Drops, packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: Rugby Laboratories, Livonia, MI 48152, NDC 0536-1325-94

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-0293-2024