Polyvinyl Alcohol Ophthalmic Solution 1.4%, Moisturizing Lubricant Eye Drops, 0.5 FL OZ (15 mL) b...

FDA Recall #D-0176-2025 — Class III — December 18, 2024

Recall #D-0176-2025 Date: December 18, 2024 Classification: Class III Status: Ongoing

Product Description

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

Reason for Recall

LABELING: LABEL MIX-UP

Recalling Firm

AvKARE — Pulaski, TN

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Distribution

Nationwide within the United States

Code Information

Lot #: 0160, Exp. Date April 26 2026

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated