FDA Recalls Cinacalcet 30mg Tablets for N-nitroso Impurity
Aurobindo Pharma USA is recalling Cinacalcet 30mg tablets nationwide due to N-nitroso Cinacalcet impurity above FDA limits. Patients should contact their healthcare provider about their medication.
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 recall involving a potentially genotoxic chemical impurity (N-nitroso compound) in a prescription medication. Although no illnesses or injuries have been reported in the source text, N-nitroso compounds represent a theoretical but significant risk of harm, qualifying this as a high-risk preventive recall.
Plain-English summary
Aurobindo Pharma USA, Inc. is recalling all Cinacalcet 30mg tablets distributed nationwide due to the presence of N-nitroso Cinacalcet, a chemical impurity, above FDA regulatory limits. Approximately 102,576 bottles are affected, with lot numbers including CFSA23001A, CFSA23002A, CFSA23003A, CFSA23004A, CFSA23005A, P2300191, P2300192, P2300193, and P2300194. Expiration dates range through October 2025.
The impurity was identified due to Current Good Manufacturing Practice (cGMP) deviations during production of the drug, which is manufactured in India. N-nitroso compounds are recognized as potentially genotoxic substances that raise regulatory health and safety concerns.
Cinacalcet is a prescription medication used to treat secondary hyperparathyroidism in patients with chronic kidney disease. Patients currently taking affected tablets should contact their healthcare provider immediately for guidance. Do not stop taking the medication without consulting a doctor, as abruptly discontinuing Cinacalcet could be harmful.
Healthcare providers should assess patients taking affected lots and determine the appropriate course of action, which may include returning medication to the pharmacy or transitioning to an alternative therapy.
The recalled product
- Product
- CINACALCET (CINACALCET)
- Brand
- CINACALCET
- Manufacturer
- Aurobindo Pharma USA Inc
- Category
- Drug — Prescription / Generic
- Hazard
- n-nitroso-impurity
- 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 (13)
- Lot #: a) CFSA23001A
- CFSA23002A
- CFSA23003A
- Exp 03/31/2025
- CFSA23004A
- Exp 07/31/2025
- CFSA23005A
- Exp 10/31/2025
- b) P2300191
- P2300192
- P2300193
- P2300194
- Exp 12/31/2024
Distribution
Distributed nationwide across the United States.
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