# FDA recall D-0144-2024

> **Novartis Pharmaceuticals Corporation** · Class I · drug recall initiated 2023-11-22.

## 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

## Reason for recall

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

## Distribution

Nationwide within the United States

## Key facts

- **Recall number:** D-0144-2024
- **Recalling firm:** Novartis Pharmaceuticals Corporation
- **Classification:** Class I
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2023-11-22
- **Report date:** 2023-12-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** East Hanover, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0144-2024

## Citation

> AI Analytics. FDA recall D-0144-2024. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-0144-2024. Source: US FDA. Licensed CC0.

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