Accord Healthcare recalls Cinacalcet 30mg tablets due to nitrosamine impurity exceeding safe limits. Affected lots from 2021-2025 may pose health risks. Consumers should check product details and contact manufacturer.
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Accord Healthcare is recalling Cinacalcet 30mg tablets that contain a harmful nitrosamine impurity above safe levels. This could cause health issues if taken regularly. The recall affects specific batches sold between 2021 and 2025.
The tablets contain N-nitroso-cinacalcet, a nitrosamine impurity that exceeds the acceptable daily intake limits. This impurity could lead to health risks with long-term use, though the exact harm isn't specified in the recall.
People prescribed Cinacalcet 30mg tablets by a doctor who own the recalled batches (NDC 16729-440-10 or 16729-440-15) are affected. Those using the medication for conditions like hyperparathyroidism are most at risk.
Check for the product name 'Cinacalcet Tablets 30 mg, Rx Only' with NDC codes 16729-440-10 or 16729-440-15. The affected batches have specific lot numbers and expiry dates listed in the recall notice.
Identify the NDC code and lot number on the tablet packaging to confirm if it's in the recalled batches.
The recall is due to the presence of a nitrosamine impurity (N-nitroso-cinacalcet) exceeding safe levels in the medication.
The recall record does not specify a remedy, so contact Accord Healthcare directly for guidance.
Yes, specific lot numbers and expiry dates are listed in the recall notice for both 30-tablet and 90-tablet bottles.
We’ve drafted a message you can send Accord Healthcare to request your refund or repair — edit it as you like.
Subject: Recall D-0030-2025 — Accord Healthcare Accord Healthcare Hello, I own a Accord Healthcare that is covered by recall D-0030-2025 from Accord Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
