D-0176-2025 Class III Ongoing
FDA drug recall D-0176-2025 was initiated by AvKARE on December 18, 2024 and is designated Class III. Reason for recall: LABELING: LABEL MIX-UP The recall status is ongoing. Affected quantity: 0.
Recall Details
- Product Type
- Drugs
- Report Date
- January 8, 2025
- Initiation Date
- December 18, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 0
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
Distribution Pattern
Nationwide within the United States
Code Information
Lot #: 0160, Exp. Date April 26 2026