Drug 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.
D-1543-2022
Product summary
- Event
- Event 90862
- Status
- Terminated
- Classification
- Class II
- Quantity
- 132,999 cartons
- Official record key
drug-enforcement:D-1543-2022
Official wording
Reason: CGMP deviations: Out of specification results obtained during routine stability testing for ethanol content.
Code information: Lot # APCD162, Exp. 01/2023
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Manufacturing or process control
CGMP deviations
-
Potency or specification failure
Out of specification