September 2023 FDA Recall Drug by Novartis Pharmaceuticals Corp.
D-1174-2023 - Crystallization

This Class I drug recall was voluntarily initiated by Novartis Pharmaceuticals Corp. on September 8, 2023 for the product Drug. The FDA reported the reason for recall as crystallization. The product was distributed Nationwide and the recall is currently ongoing.

Recall Number: D-1174-2023

Reason for Recall
Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals.
Initiated
09-08-2023
Reported
09-27-2023
Quantity
1272 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
92975
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Novartis Pharmaceuticals Corp.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# FX001691, Exp. 12/31/2025