FDA Recall D-1174-2023

Novartis Pharmaceuticals Corp. · East Hanover, NJ

Class I — life-threatening Ongoing 979 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

SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL bottle, Rx Only, Manufactured by: DELPHARM Huningue S.A.S., Huningue, France, Distributed by: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936, NDC 0078-0110-22.

Lot / code: FX001691, Exp. 12/31/2025

Quantity: 1272 bottles

Reason for recall

Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals.

Recall record

Recall number: D-1174-2023
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the USA
Recall initiated: 2023-09-08
Classified by FDA Center: 2023-09-21
FDA published: 2023-09-27
Recalling firm: Novartis Pharmaceuticals Corp.
Firm location: East Hanover, NJ

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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