PlainRecalls
FDA Drug Critical Class I Ongoing

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

Reported: February 14, 2024 Initiated: November 13, 2023 #D-0293-2024

Product Description

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

Details

Units Affected
1,492,344 bottles
Distribution
Nationwide within the United States
Location
Navi Mumbai

Frequently Asked Questions

What product was recalled?
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. Recalled by Kilitch Healthcare India Limited. Units affected: 1,492,344 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-0293-2024.