September 2022 FDA Recall Neoral by Novartis Pharmaceuticals Corporation
D-1543-2022 - CGMP deviations
This Class II drug recall was voluntarily initiated by Novartis Pharmaceuticals Corporation on September 16, 2022 for the product Neoral. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1543-2022
CGMP deviations: Out of specification results obtained during routine stability testing for ethanol content.
09-16-2022
10-05-2022
132,999 cartons
Recall Profile & Regulatory Data
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Novartis Pharmaceuticals Corporation
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and Puerto Rico
03-11-2024
Product Description About Product Description
Full technical description of the product.
Full technical description of 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.
Batch or Lot Expiration Information
Lot# APCD162, Exp. 01/2023
