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Recall Observatory FDA recall evidence

Drug product

Refresh Relieva PF Preservative-Free Lubricant Eye Drops 0.33 fl oz (10 mL) Sterile Distributed by: Allergan, an AbbVie company Madison, NJ 07940 UPC 3 00236 63410 0, NDC 0023-6634-10.

D-0233-2021

December 30, 2020

Class II

Product summary

Firm
Allergan, PLC.
Event
Event 87016
Status
Terminated
Classification
Class II
Quantity
100,634 bottles
Official record key
drug-enforcement:D-0233-2021

Official wording

Reason: Labeling: Missing instructions for use insert

Code information: Lots: T0392 Exp. Jul. 2022, T0843 Exp. Aug. 2022

Distribution pattern: Nationwide.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Missing