Cinacalcet Tablets Recalled Due to Nitrosamine Impurity
Accord Healthcare recalls Cinacalcet 60mg tablets nationwide because N-nitroso-cinacalcet impurity was detected above acceptable daily intake limits. The contamination resulted from manufacturing process deviations.
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: FDA Class II recall with no reported illnesses or hospitalizations. The hazard—nitrosamine impurity above acceptable daily intake limits—represents a risk-of-harm product where injury has not yet been reported, meeting the Score 3 criterion.
Plain-English summary
Accord Healthcare, Inc. is recalling Cinacalcet tablets, 60 mg strength, distributed nationwide in the United States and Puerto Rico. The recall affects two package sizes: 30 tablets per bottle (NDC 16729-441-10) and 90 tablets per bottle (NDC 16729-441-15). The affected lots have expiry dates ranging from February 2025 through October 2025.
The recall was initiated due to the presence of N-nitroso-cinacalcet, a nitrosamine impurity, detected above acceptable daily intake limits. Manufacturing process deviations resulted in this contamination.
Patients currently taking the affected lots of Cinacalcet should not stop their medication without consulting their healthcare provider. Check the lot number and expiry date on your medication bottle against the published recall list. If you have an affected lot, contact your healthcare provider or pharmacist for guidance on continuing your treatment safely.
Healthcare providers and pharmacists should check inventory for affected lots and quarantine any recalled product.
The recalled product
- Product
- CINACALCET (CINACALCET)
- Brand
- CINACALCET
- Manufacturer
- ACCORD HEALTHCARE, INC.
- Hazard
- nitrosamine
- chemical-impurity
Distribution
Distributed nationwide across the United States.
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