Recalls / Class II
Class IID-1543-2022
Product
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.
- Brand name
- Neoral
- Generic name
- Cyclosporine
- Active ingredient
- Cyclosporine
- Route
- Oral
- NDCs
- 0078-0246, 0078-0248, 0078-0274
- FDA application
- NDA050715
- Affected lot / code info
- Lot # APCD162, Exp. 01/2023
Why it was recalled
CGMP deviations: Out of specification results obtained during routine stability testing for ethanol content.
Recalling firm
- Firm
- Novartis Pharmaceuticals Corporation
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Health Plz, N/A, East Hanover, New Jersey 07936-1016
Distribution
- Quantity
- 132,999 cartons
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2022-09-16
- FDA classified
- 2022-09-26
- Posted by FDA
- 2022-10-05
- Terminated
- 2024-03-11
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1543-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.