FDA recall D-0176-2025

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

Reason for recall

LABELING: LABEL MIX-UP

Distribution

Nationwide within the United States

Key facts

Status

Ongoing

Initiation date

2024-12-18

Report date

2025-01-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Pulaski, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0176-2025