FDA Recall D-0293-2024

Kilitch Healthcare India Limited

Class I — life-threatening Ongoing 913 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death. Distribution is nationwide and the recall remains in progress.

Product

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

Lot / code: All lots

Quantity: 1,492,344 bottles

Reason for recall

Non-Sterility

Recall record

Recall number: D-0293-2024
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Press Release
Distribution: Nationwide within the United States
Recall initiated: 2023-11-13
Classified by FDA Center: 2024-02-05
FDA published: 2024-02-14
Recalling firm: Kilitch Healthcare India Limited

Operational response

A Class I recall indicates a strong likelihood of serious adverse health consequence or death. Pull affected lots from active dispensing immediately. Segregate inventory in a marked, locked location pending destruction or return. If product has already been dispensed, identify affected patients and contact them by your standard recall-notification protocol.

For the official FDA enforcement record, see FDA's Recall Search.

‹ All recalls