Cinacalcet tablets recalled for nitrosamine impurity above acceptable limits
Cipla USA recalls 12,576 bottles of cinacalcet 90 mg tablets nationwide due to manufacturing deviations resulting in nitrosamine impurity levels exceeding acceptable daily intake 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: FDA Class II recall for prescription drug contaminated with nitrosamine impurity above acceptable daily intake limits. This qualifies as a risk-of-harm product where no illnesses have been reported, meeting the High severity criterion.
Plain-English summary
Cipla USA, Inc. is recalling cinacalcet hydrochloride tablets, 90 mg strength, due to manufacturing process deviations resulting in nitrosamine contamination. The presence of N-nitroso-cinacalcet, a nitrosamine impurity, was detected at levels above acceptable daily intake limits.
The affected product is Cinacalcet Hydrochloride Tablets, 90 mg, 30 tablets per bottle (NDC 69097-412-02, Lot 5PB0183, expiration date 1/31/2027). Approximately 12,576 bottles were distributed nationwide in the United States.
This is a Class II recall issued by the Food and Drug Administration for Cipla USA, Inc.
The recalled product
- Product
- CINACALCET (CINACALCET)
- Brand
- CINACALCET
- Manufacturer
- Cipla USA, Inc.
- Category
- Drug
- Hazard
- nitrosamine-impurity
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 (2)
- Lot 5PB0183
- exp 1/31/2027
Distribution
Distributed nationwide across the United States.
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- HighCinacalcet tablets recalled due to N-nitroso impurity above acceptable limits
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- HighDrug Recall: Cinacalcet tablets contain excess nitrosamine impurity
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- HighPrescription Drug Cinacalcet Tablets Recalled Due to Nitrosamine Impurity
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