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Recall Observatory FDA recall evidence

Drug product

Leader brand Dry Eye Relief (Polyethylene glycol 400 0.4% and Propylene glycol 0.3%) packaged in 0.33 FL OZ (10 mL) bottles, Distributed by Cardinal Health Dublin, Ohio 43017, NDC 70000-0088-1

D-0295-2024

November 13, 2023

Class I

Product summary

Firm
Kilitch Healthcare India Limited
Event
Event 93357
Status
Ongoing
Classification
Class I
Quantity
12,960 bottles
Official record key
drug-enforcement:D-0295-2024

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