FDA Recall D-0301-2024

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

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

Lot / code: All lots

Quantity: 14,784 bottles

Reason for recall

Non-Sterility

Recall record

Recall number: D-0301-2024
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.

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