Neoral Solution
FDA Recall NDC 0078-0274
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Neoral (NDC 0078-0274). A significant event, classified as Class II, was initiated on Sep 16, 2022 by Novartis Pharmaceuticals Corporation. The reported reason for this action was: "CGMP deviations: Out of specification results obtained during routine stability testing for ethanol content."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
CGMP deviations: Out of specification results obtained during routine stability testing for ethanol content.
Sep 16, 2022
Oct 05, 2022
132,999 cartons
Recall Profile & Regulatory Data
Event ID
90862
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Novartis Pharmaceuticals Corporation
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico
Termination Date
Mar 11, 2024
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.
Batch or Lot Expiration Information
Lot# APCD162, Exp. 01/2023
Affected Packages Involved in this Recall
0078-0246-61Product
0078-0246-15Product
0078-0248-61Product
0078-0248-15Product
0078-0274-22Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
