Cinacalcet 90 mg tablets recalled over a nitrosamine impurity above limits
Cipla USA is recalling 12,576 bottles of Cinacalcet Hydrochloride Tablets, 90 mg, over the presence of N-nitroso-cinacalcet above the 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: Scored 3 under the risk-of-harm criterion: an impurity present above the acceptable daily intake limit is a stated product defect, and no injuries are reported.
Plain-English summary
Cinacalcet Hydrochloride Tablets, 90 mg, 30 tablets per bottle, manufactured for Cipla USA, Inc. of Warren, New Jersey, under NDC 69097-412-02, are being recalled.
The recall follows CGMP deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
The recall covers 12,576 bottles from lot 5PB0183, expiry 1/31/2027. Distribution was nationwide in the US. The FDA has classified the action as Class II.
Patients should not stop taking a prescribed medicine without speaking to their prescriber or pharmacist, who can confirm whether a specific bottle is affected and arrange a replacement.
The recalled product
- Product
- CINACALCET (CINACALCET)
- Brand
- CINACALCET
- Manufacturer
- Cipla USA, Inc.
- Category
- Drug — Calcimimetic
- Affected units
- 12,576
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.
Part of a larger recall action
This product is one of 3 recalled by Cipla USA, 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
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- SevereCinacalcet Tablets Recalled for cGMP Deviations
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