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.
Class II · Terminated
CGMP deviations: Out of specification results obtained during routine stability testing for ethanol content.
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Affected lots / codes — check yours against thisLot # APCD162, Exp. 01/2023
- Recalling firm
- Novartis Pharmaceuticals Corporation, East Hanover, NJ
- Classification
- Class II (temporary or reversible harm possible)
- Status
- Terminated
- Quantity
- 132,999 cartons
- Distribution
- Nationwide and Puerto Rico
- Recall initiated
- September 16, 2022
- Classified
- September 26, 2022
- Terminated
- March 11, 2024
- Initiation
- Voluntary: Firm initiated
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Official source. This record is published by the U.S. FDA through the openFDA
enforcement database. View the unmodified government record:
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-1543-2022%22
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-1543-2022%22
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Important. Recalls target specific lots and codes — compare the affected lots
above against your own product. This page reproduces public FDA data for readability;
EveryRecall is independent and not affiliated with the FDA.
Check this brand across all 8 databases →