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Recall Observatory FDA recall evidence

Drug product

Leader brand Lubricant Eye Drops (Carboxymethylcellulose Sodium 0.5%), packaged in a) 0.5 FL OZ (15mL) bottles (Single Pack) (NDC 70000-0090-1) and b) 0.5 FL OZ (15 mL) bottles (Twin pack) (NDC 70000-0090-2), Distributed by: Cardinal Health Dublin, Ohio 43017

D-0291-2024

November 13, 2023

Class I

Product summary

Firm
Kilitch Healthcare India Limited
Event
Event 93357
Status
Ongoing
Classification
Class I
Quantity
210,192 bottles
Official record key
drug-enforcement:D-0291-2024

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