Recall Enforment Report D-1543-2022

Drug Recall Enforcement Report Class II voluntary initiated by Novartis Pharmaceuticals Corporation, originally initiated on 09-16-2022 for the 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. The product was recalled due to cgmp deviations: out of specification results obtained during routine stability testing for ethanol content.. The product was distributed nationwide and the recall is currently completed.

Field Name Field Value
Event ID 90862 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number D-1543-2022 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern Nationwide and Puerto Rico What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
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.
Reason For Recall CGMP deviations: Out of specification results obtained during routine stability testing for ethanol content. What is the Reason for Recall?
Information describing how the product is defective.
Product Quantity 132,999 cartons Product Quantity
The amount of product subject to recall.
Voluntary Mandated Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date 10-05-2022
Recall Initiation Date 09-16-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall.
Initial Firm Notification Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type Drugs
Recalling Firm Novartis Pharmaceuticals Corporation
Code Info Lot # APCD162, Exp. 01/2023 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages 0078-0246-61; 0078-0246-15; 0078-0248-61; 0078-0248-15; 0078-0274-22
Status Completed - A recall which has reached the point at which the firm has actually retrieved and impounded all outstanding product that could reasonably be expected to be recovered, or has completed all product corrections.

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
0078-0246Neoral CyclosporineCapsule, Liquid FilledOralNovartis Pharmaceuticals CorporationHuman Prescription Drug
0078-0248Neoral CyclosporineCapsule, Liquid FilledOralNovartis Pharmaceuticals CorporationHuman Prescription Drug
0078-0274Neoral CyclosporineSolutionOralNovartis Pharmaceuticals CorporationHuman Prescription Drug