FDA recall D-0175-2025

AvKARE · Class III · 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.

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-0175-2025