FDA-Drug2024-02-14Class I

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

Kilitch Healthcare India Limited
Hazard

Non-Sterility

Sold states
Nationwide within the United States
Affected count
56,520 bottles
Manufactured in
R - 904 905 T T C Industrial Road, Navi Mumbai, India
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0310-2024

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