FDA Recalls Neoral Cyclosporine for Out-of-Specification Ethanol Content
Novartis is recalling Neoral cyclosporine 25 mg capsules nationwide due to a manufacturing quality deviation. Lot APCD162 (expiration 01/2023) was found to have out-of-specification ethanol content during stability testing.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II drug recall involving a manufacturing quality deviation in a prescription immunosuppressant. While no illnesses or injuries have been reported and the deviation was detected during routine stability testing, out-of-specification content in a serious medication represents a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Novartis Pharmaceuticals Corporation is recalling Neoral (cyclosporine) soft gelatin capsules, 25 mg, due to manufacturing quality deviations. During routine stability testing, the ethanol content was found to be out of specification.
The recall involves Lot APCD162, which has an expiration date of January 2023. A total of 132,999 cartons were distributed nationwide and to Puerto Rico.
Cyclosporine is an oral immunosuppressant medication. Patients currently taking this medication should contact their healthcare provider or pharmacist to verify the lot number of their medication and determine whether they have the recalled lot.
The recalled product
- Product
- NEORAL (CYCLOSPORINE)
- Brand
- NEORAL
- Manufacturer
- Novartis Pharmaceuticals Corporation
- Category
- Drug — Immunosuppressant
- Hazard
- out-of-specification
- manufacturing-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # APCD162
- Exp. 01/2023
Distribution
Distributed nationwide across the United States.
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