D-1543-2022 Class II Terminated
FDA drug recall D-1543-2022 was initiated by Novartis Pharmaceuticals Corporation on Sep 16, 2022 and is designated Class II. Reason for recall: CGMP deviations: Out of specification results obtained during routine stability testing for ethanol content. The recall status is terminated (terminated Mar 11, 2024). Affected quantity: 132,999 cartons.
Recall details
- Product Type
- Drugs
- Report Date
- Oct 5, 2022
- Initiation Date
- Sep 16, 2022
- Termination Date
- Mar 11, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 132,999 cartons
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.
Distribution pattern
Nationwide and Puerto Rico
Code information
Lot # APCD162, Exp. 01/2023
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1543-2022
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026