Cinacalcet Tablets Recalled for N-Nitroso Impurity Exceeding Limits
Cipla USA, Inc. is recalling Cinacalcet Hydrochloride 30 mg tablets due to the presence of N-nitroso-cinacalcet above the acceptable daily intake. The affected product was distributed nationwide.
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: The FDA classified this as a Class II recall. The hazard involves an N-nitroso impurity above acceptable levels, which is a potential carcinogenic risk. Although no reported illnesses are stated in the source, this represents a risk-of-harm product with a known chemical contamination exceeding safety thresholds, warranting a High severity classification.
Plain-English summary
Cipla USA, Inc. is recalling Cinacalcet Hydrochloride Tablets, 30 mg, 30-count bottles (NDC 69097-410-02), manufactured by Cipla Ltd. in India. A total of 31,824 bottles have been recalled. The recall was initiated because of the presence of N-nitroso-cinacalcet above the acceptable daily intake, a deviation from current good manufacturing practice (cGMP) standards.
The affected product was distributed nationwide. Affected lot numbers include 5PB0465, 5PB0466, and 5PB0557 (expiring 4/30/2027), as well as 5PB0629, 5PB0630, 5PB0633, 5PB0637, and 5PB0638 (expiring 6/30/2027).
Patients currently taking this medication should contact their healthcare provider or pharmacist for guidance on their treatment. Healthcare providers and pharmacists should stop dispensing product from the affected lots and quarantine remaining inventory.
The recalled product
- Product
- CINACALCET (CINACALCET)
- Brand
- CINACALCET
- Manufacturer
- Cipla USA, Inc.
- Category
- Drug — Prescription Tablet
- 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 (10)
- Lot #: 5PB0465
- 5PB0466
- 5PB0557
- Exp 4/30/2027
- 5PB0629
- 5PB0630
- 5PB0633
- 5PB0637
- 5PB0638
- Exp 6/30/2027
Distribution
Distributed nationwide across the United States.
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- SevereCinacalcet Hydrochloride Tablets Recalled for Elevated Impurity Levels
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- SevereCinacalcet Tablets Recalled for cGMP Deviations
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- HighPrescription Cinacalcet Tablets Recalled for N-Nitroso Impurity
FDA (Drugs) · 2024-12-11
- HighCinacalcet Tablets Recalled for N-Nitroso Impurity Exceeding FDA Safety Limit
FDA (Drugs) · 2024-12-11
- HighFDA Recalls Cinacalcet 30mg Tablets for N-nitroso Impurity
FDA (Drugs) · 2024-12-11
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