Accord Healthcare Recalls Cinacalcet Tablets Due to Nitrosamine Contamination
Accord Healthcare is recalling Cinacalcet 30mg tablets nationwide due to a nitrosamine impurity (N-nitroso-cinacalcet) exceeding acceptable daily intake limits. Patients should consult their healthcare provider to confirm if their medication is affected.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 for a pharmaceutical contaminant (nitrosamine) exceeding acceptable daily intake limits. No reported illnesses or injuries are stated in the source, making the hazard theoretical rather than realized, which caps the score at 3 per the rubric.
Plain-English summary
Accord Healthcare, Inc. is recalling Cinacalcet 30mg tablets in a nationwide recall in the United States and Puerto Rico. The affected product is available in two package sizes: 30 tablets per bottle (NDC: 16729-440-10) and 90 tablets per bottle (NDC: 16729-440-15).
The recall is due to Current Good Manufacturing Practice (CGMP) deviations involving the detection of a nitrosamine impurity, N-nitroso-cinacalcet, present in the product at levels exceeding the acceptable daily intake (ADI) limit.
Patients taking Cinacalcet from the affected lot numbers should contact their healthcare provider or pharmacist to determine if their medication is included in the recall. Patients should not stop taking their medication without consulting their healthcare provider.
For more information about the affected lot numbers and expiry dates, patients and healthcare providers should contact Accord Healthcare, Inc. or check the FDA's official recall notice.
The recalled product
- Product
- CINACALCET (CINACALCET)
- Brand
- CINACALCET
- Manufacturer
- ACCORD HEALTHCARE, INC.
Distribution
Part of a larger recall action
This product is one of 3 recalled by ACCORD HEALTHCARE, INC. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same brand · CINACALCET
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Same manufacturer · ACCORD HEALTHCARE, INC.
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Same hazard · nitrosamine
See all →- SevereFDA Recalls Mirabegron Tablets Over Nitrosamine Impurity
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- HighDuloxetine 30mg delayed-release capsules exceed nitrosamine impurity interim limit
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- ModerateBisoprolol and hydrochlorothiazide tablets recalled over a nitrosamine impurity
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- HighClomipramine 25 mg capsules recalled over nitrosamine above the intake limit
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Similar recalls
- HighCinacalcet tablets recalled for manufacturing impurity exceeding FDA limits
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- HighCinacalcet 30 mg tablets recalled over a nitrosamine impurity above limits
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