Skip to content
Recall Observatory FDA recall evidence

Drug product

Leader brand Eye Irritation Relief (Polyvinyl alcohol 0.5%, Povidone 0.6%, Tetrahydrozoline 0.05%), packaged in 0.5 FL OZ (15 mL) bottles, Cardinal Health Dublin, Ohio 43017, NDC 70000-0087-1

D-0297-2024

November 13, 2023

Class I

Product summary

Firm
Kilitch Healthcare India Limited
Event
Event 93357
Status
Ongoing
Classification
Class I
Quantity
10,944 bottles
Official record key
drug-enforcement:D-0297-2024

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