Class II
Terminated
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.
- Recall Initiated
- September 16, 2022
- Posted
- October 5, 2022
- Recall Number
- D-1543-2022
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 132,999 cartons
- Firm Location
- East Hanover, NJ, United States
Reason for Recall
CGMP deviations: Out of specification results obtained during routine stability testing for ethanol content.
Distribution
Nationwide and Puerto Rico
Lot / Code Info
Lot # APCD162, Exp. 01/2023
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