Novartis Pharmaceuticals Corp.: Drug Recall
Recall #D-1174-2023 · 09/08/2023
Class I: Dangerous
Recall Details
- Recall Number
- D-1174-2023
- Classification
- Class I
- Product Type
- Drug
- Recalling Firm
- Novartis Pharmaceuticals Corp.
- Status
- Ongoing
- Date Initiated
- 09/08/2023
- Location
- East Hanover, NJ, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1272 bottles
Reason for Recall
Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals.
Product Description
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.
Distribution Pattern
Nationwide in the USA
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.