Rugby brand Polyvinyl Alcohol 1.4% Lubricating Eye Drops, packaged in 0.5 FL OZ (15 mL) bottles, ...
FDA Recall #D-0293-2024 — Class I — November 13, 2023
Product Description
Rugby brand Polyvinyl Alcohol 1.4% Lubricating Eye Drops, packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: Rugby Laboratories, Livonia, MI 48152, NDC 0536-1325-94
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
1,492,344 bottles
Distribution
Nationwide within the United States
Code Information
All lots
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated