Novartis Recalls One Lot of Sandimmune Oral Solution 100 mg/mL
On September 11, 2023, Novartis Pharmaceuticals Inc. voluntarily recalled one lot of Sandimmune Oral Solution (Cyclosporine Oral Solution, USP) 100 mg/mL distributed in the U.S from April 2023 to September 2023 on the consumer level. There are no current adverse events reported for Sandimmune related to this recall.
To date, Novartis has received no reports of adverse events related to recalled lot. However, Novartis is recalling product in this lot due to the concern of crystallization that may cause incorrect dosing and potentially lead to graft rejection/loss or alternatively cyclosporine toxicity.
The following lot has been recalled and is listed in the table below:
| Product | Lot No | Expiry | Distribution Dates |
| Sandimmune Oral Solution | FX001691 | Dec. 2025 | April 2023 to September 2023 |
Novartis is contacting its distributors through recall notification and is arranging for the return of all recalled product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Reference:
- FDA MedWatch.Recalls, Market Withdrawals & Safety Alerts. Retrieved September 12, 2023 from:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/novartis-issues-voluntary-nationwide-recall-one-lot-sandimmuner-oral-solution-cyclosporine-oral