Leader brand Lubricant Eye Drops (Propylene glycol Eye Drops 0.6%), packaged in 0.33 FL OZ (10 mL...

FDA Recall #D-0301-2024 — Class I — November 13, 2023

Recall #D-0301-2024 Date: November 13, 2023 Classification: Class I Status: Ongoing

Product Description

Leader brand Lubricant Eye Drops (Propylene glycol Eye Drops 0.6%), packaged in 0.33 FL OZ (10 mL) bottles, Cardinal Health Dublin, Ohio 43017, NDC 70000-0587-1

Reason for Recall

Non-Sterility

Recalling Firm

Kilitch Healthcare India Limited — Navi Mumbai

Classification

Class I — Reasonable probability of serious adverse health consequences or death.

Product Type

Drugs

Product Quantity

14,784 bottles

Distribution

Nationwide within the United States

Code Information

All lots

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated