Prescription Cinacalcet Tablets Recalled for N-Nitroso Impurity
Aurobindo Pharma USA Inc is recalling Cinacalcet 60mg tablets nationwide due to N-nitroso Cinacalcet impurity exceeding FDA recommended interim limits.
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 of a pharmaceutical product containing a chemical impurity without reported illnesses or injuries. Per the severity rubric, this constitutes a risk-of-harm product where injury has not yet been reported, warranting a High (3) classification.
Plain-English summary
Aurobindo Pharma USA Inc is recalling Cinacalcet 60mg tablets due to N-nitroso Cinacalcet impurity found above FDA recommended interim limits. Manufacturing process deviations resulted in this contamination.
The recall affects 3,336 bottles distributed nationwide. Affected products are Cinacalcet 60mg in 30-count HDPE bottles (NDC 65862-832-30) and 500-count HDPE bottles (NDC 65862-832-05) with lot numbers CFSB23001A (exp. 03/31/2025), CFSB23002A (exp. 07/31/2025), CFSB23003A (exp. 10/31/2025), CFSB23004A (exp. 10/31/2025), and P2300196 (exp. 12/31/2024).
Patients should consult with their healthcare provider if they have questions about their medication or if they believe they may have an affected lot.
The recalled product
- Product
- CINACALCET (CINACALCET)
- Brand
- CINACALCET
- Manufacturer
- Aurobindo Pharma USA Inc
- Category
- Drug
- Hazard
- n-nitroso-impurity
- cgmp-deviation
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 (9)
- Lot #: a) CFSB23001A
- Exp 03/31/2025
- CFSB23002A
- Exp 07/31/2025
- CFSB23003A
- Exp 10/31/2025
- CFSB23004A
- b) P2300196
- 12/31/2024
Distribution
Distributed nationwide across the United States.
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