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Recall Observatory FDA recall evidence

Drug product

Polyvinyl Alcohol Ophthalmic Solution 1.4%, Moisturizing Lubricant Eye Drops, 0.5 FL OZ (15 mL) bottles, Distributed by AvKARE, Pulaski, TN 38478, www.avkare.com, NDC 50268-678-15

D-0176-2025

December 18, 2024

Class III

Product summary

Firm
AvKARE
Event
Event 96032
Status
Ongoing
Classification
Class III
Quantity
0
Official record key
drug-enforcement:D-0176-2025

Official wording

Reason: LABELING: LABEL MIX-UP

Code information: Lot #: 0160, Exp. Date April 26 2026

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    LABELING: LABEL MIX-UP