Neoral soft gelatin capsules (cyclosporine capsules, USP) Modified, 25 mg, Rx Only, 30 Soft Gelatin Capsules per carton,
Summary
The FDA issued a Class II for Neoral soft gelatin capsules (cyclosporine capsules, USP) Modified, 25 mg, Rx On by Novartis Pharmaceuticals Corporation. Reason: CGMP deviations: Out of specification results obtained during routine stability testing for ethanol content..
Details
Source
Drug Recall
External ID
D-1543-2022
Action Date
2022-10-05
Status
Terminated
Category
drug
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.
Lot/Code Info: Lot # APCD162, Exp. 01/2023
Quantity Affected: 132,999 cartons
Reason for Recall
CGMP deviations: Out of specification results obtained during routine stability testing for ethanol content.
Distribution
Nationwide and Puerto Rico
Type: Voluntary: Firm initiated
Recall Initiated: 2022-09-16
Company
East Hanover, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 21 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Novartis Pharmaceuticals Corporation has 6 FDA actions in our database, including 6 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Novartis Pharmaceuticals Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Novartis Pharmaceuticals Corporation have FDA actions?
Novartis Pharmaceuticals Corporation has 6 FDA actions in our database, including 6 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-1543-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
Want to know the moment something like this happens?
Get alerts for drugRelated Actions
Semaglutide Injection, 10 mg/4 mL (2.5 mg/mL), 4mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jef
ProRx LLC · 2025-11-05
No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, Distributed by SUPERVALU IN
Perrigo Company PLC · 2022-03-02
Little Moon Essentials, Crampy Belly Rub (Camphor 1.1%), Packaged as a) 4 FL OZ (118ML) glass jar, UPC Code 6 73673 8826
Little Moon Essentials LLC · 2024-07-10
Enoxaparin Sodium Injection, USP, 150MG/ML Single-Dose Syringes with Automatic Safety Device, For Subcutaneous Injection
CARDINAL HEALTHCARE · 2024-01-03
HYDROMORPHONE (a) 1MG/ML IN NS, 50ML, 75 ML, 100ML, 175ML(NDC 00703-0018-01 and NDC 00409-2634-50) ; (b) 5MG/ML IN NS 6
Sentara Infusion Services · 2023-02-22