AvKARE: Drug Recall

Recall #D-0176-2025 · 12/18/2024

Class III: Low Risk

Recall Details

Recall Number: D-0176-2025
Classification: Class III
Product Type: Drug
Recalling Firm: AvKARE
Status: Ongoing
Date Initiated: 12/18/2024
Location: Pulaski, TN, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 0

Reason for Recall

LABELING: LABEL MIX-UP

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

Distribution Pattern

Nationwide within the United States

Other Recalls by AvKARE

Class II: Risk 12/31/2025

Out of specification for dissolution.
Class II: Risk 09/02/2025

Failed Content Uniformity Specifications
Class II: Risk 08/25/2025

Presence of a foreign substance.
Class II: Risk 08/25/2025

Presence of a foreign substance.
Class III: Low Risk 06/26/2025

Failed Impurity/Degradation Specifications

View all recalls by AvKARE →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.