Neoral soft gelatin capsules recall: CGMP Deviations
Neoral soft gelatin capsules (cyclosporine capsules, USP) Modified, 25 mg, Rx Only, 30 Soft Gelatin Capsules per carton, Mfg by: Novartis…
Why was Neoral soft gelatin capsules recalled?
CGMP deviations: Out of specification results obtained during routine stability testing for ethanol content.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot # APCD162, Exp. 01/2023
- Product
- Neoral soft gelatin capsules (cyclosporine capsules, USP) Modified, 25 mg, Rx Only, 30 Soft Gelatin Capsules per carton, Mfg by: Novartis…
- Recalling firm
- Novartis Pharmaceuticals Corporation
- Quantity
- 132,999 cartons
- Distribution
- Nationwide and Puerto Rico
- Recall date
- October 5, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)