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Recall Observatory FDA recall evidence

Drug product

Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% Moisturizing Lubricant Eye Drops, 0.5 FL OZ (15 mL) bottles, Distributed by: AvKARE, Pulaski, TN, 38478, NDC 50268-068-15.

D-0175-2025

December 18, 2024

Class III

Product summary

Firm
AvKARE
Event
Event 96032
Status
Ongoing
Classification
Class III
Quantity
16,677 cartons
Official record key
drug-enforcement:D-0175-2025

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