Novartis Pharmaceuticals Corporation: Drug Recall
Recall #D-1543-2022 · 09/16/2022
Class II: Risk
Recall Details
- Recall Number
- D-1543-2022
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Novartis Pharmaceuticals Corporation
- Status
- Terminated
- Date Initiated
- 09/16/2022
- Location
- East Hanover, NJ, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 132,999 cartons
Reason for Recall
CGMP deviations: Out of specification results obtained during routine stability testing for ethanol content.
Product Description
Neoral soft gelatin capsules (cyclosporine capsules, USP) Modified, 25 mg, Rx Only, 30 Soft Gelatin Capsules per carton, Mfg by: Novartis Pharmaceuticals Corporation, East Hanover, NJ 07936, NDC # 0078-0246-15.
Distribution Pattern
Nationwide and Puerto Rico
Other Recalls by Novartis Pharmaceuticals Corporation
- Class I: Dangerous 11/22/2023
- Class III: Low Risk 05/10/2022
- Class III: Low Risk 05/10/2022
- Class III: Low Risk 05/10/2022
- Class III: Low Risk 05/10/2022
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.