Cinacalcet 60 mg tablets recalled over a nitrosamine impurity above limits
Cipla USA is recalling 15,744 bottles of Cinacalcet Hydrochloride Tablets, 60 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, 60 mg, 30 tablets per bottle, manufactured for Cipla USA, Inc. of Warren, New Jersey, under NDC 69097-411-02, 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 15,744 bottles from lot 5PB0164, 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
- Deep-brand PREMIUM Select Mixed Vegetables 4 way KEEP FROZEN a) Net Wt. 3.85 LB. (1.75 kg); b) Net Wt. 2 LB (907 g)
- Manufacturer
- CHETAK NEW YORK LLC
- Category
- Drug — Calcimimetic
- Hazard
- nitrosamine-impurity
- cgmp-deviation
- above-adi-limit
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 (18)
- Lots: a) 24354
- 25001
- 25032
- 25035
- 25068
- 25099
- 25100
- 25122
- 25133
- 25160
- 25195
- b) 25001
- 25020
- 25044
- 25072
- 25080
- 25167
- 25198
Distribution
Distribution scope not specified by the agency.
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