Drug Recall: Cinacalcet tablets contain excess nitrosamine impurity
Cipla USA is recalling 15,744 bottles of Cinacalcet 60 mg tablets nationwide due to a manufacturing control deviation: N-nitroso-cinacalcet impurity above 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 involving N-nitroso-cinacalcet, a known carcinogenic impurity present above acceptable limits. Qualifies as a risk-of-harm product where injury has not yet been reported, with no hospitalization or illness reports to elevate it to Severe.
Plain-English summary
Cipla USA, Inc. is recalling 15,744 bottles of Cinacalcet Hydrochloride Tablets, 60 mg strength, due to a manufacturing control deviation. Testing identified N-nitroso-cinacalcet, a nitrosamine impurity, present above the FDA's acceptable daily intake limits.
The affected product is Lot 5PB0164 with an expiration date of January 31, 2027. Distribution was nationwide throughout the United States. No illnesses or injuries related to this product have been reported.
Patients currently taking Cinacalcet should not discontinue their medication without consulting their healthcare provider. Consumers who have this product should contact their pharmacy or healthcare provider for further guidance and instructions on returning the medication for proper disposal.
The recalled product
- Product
- CINACALCET (CINACALCET)
- Brand
- CINACALCET
- Manufacturer
- Cipla USA, Inc.
- Category
- Drug
- Hazard
- nitrosamine
- manufacturing-defect
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 5PB0164
- exp 1/31/2027
Distribution
Distributed nationwide across the United States.
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