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Recall Observatory FDA recall evidence

Drug product

Target brand High Performance Lubricant Eye Drops (Polyethylene glycol 400 0.4%, Propylene glycol 0.3%) a) 0.5 FL OZ (15mL) bottles (Single Pack) (NDC 11673-522-15) and b) 0.5 FL OZ (15 mL) bottles (Twin pack) (NDC 11673-522-30), Distributed by: Target Corporation Minneapolis, MN 55403

D-0300-2024

November 13, 2023

Class I

Product summary

Firm
Kilitch Healthcare India Limited
Event
Event 93357
Status
Ongoing
Classification
Class I
Quantity
401,568 bottles
Official record key
drug-enforcement:D-0300-2024

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