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Recall Observatory FDA recall evidence

Drug product

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

D-0310-2024

November 13, 2023

Class I

Product summary

Firm
Kilitch Healthcare India Limited
Event
Event 93357
Status
Ongoing
Classification
Class I
Quantity
56,520 bottles
Official record key
drug-enforcement:D-0310-2024

Official wording

Reason: Non-Sterility

Code information: All lots

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Non-Sterility