FDA Recall D-0291-2024

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 (Carboxymethylcellulose Sodium 0.5%), packaged in a) 0.5 FL OZ (15mL) bottles (Single Pack) (NDC 70000-0090-1) and b) 0.5 FL OZ (15 mL) bottles (Twin pack) (NDC 70000-0090-2), Distributed by: Cardinal Health Dublin, Ohio 43017

Lot / code: All lots

Quantity: 210,192 bottles

Reason for recall

Non-Sterility

Recall record

Recall number: D-0291-2024
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

Drug identification

Brand name(s): LUBRICANT DROPS
Generic name(s): CARBOXYMETHYLCELLULOSE SODIUM
Manufacturer(s): CARDINAL HEALTH 110, LLC. DBA LEADER
NDC(s): 70000-0090
Route(s): OPHTHALMIC

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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