PlainRecalls
FDA Drug Critical Class I Ongoing

Rugby brand Lubricating Tears Eye Drops (Dextran 70 0.1%, Hypromellose 2910 0.3%), packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: Rugby Laboratories, Livonia, MI 48152, NDC 0536-1282-94

Reported: February 14, 2024 Initiated: November 13, 2023 #D-0310-2024

Product Description

Rugby brand Lubricating Tears Eye Drops (Dextran 70 0.1%, Hypromellose 2910 0.3%), packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: Rugby Laboratories, Livonia, MI 48152, NDC 0536-1282-94

Reason for Recall

Non-Sterility

Details

Units Affected
56,520 bottles
Distribution
Nationwide within the United States
Location
Navi Mumbai

Frequently Asked Questions

What product was recalled?
Rugby brand Lubricating Tears Eye Drops (Dextran 70 0.1%, Hypromellose 2910 0.3%), packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: Rugby Laboratories, Livonia, MI 48152, NDC 0536-1282-94. Recalled by Kilitch Healthcare India Limited. Units affected: 56,520 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-0310-2024.