AvKARE recalls 90mg Cinacalcet tablets due to nitrosamine impurity exceeding safety limits. This medication, prescribed for high calcium levels, may pose health risks if used without proper safety checks.
CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.
AvKARE is recalling 90mg Cinacalcet tablets (30-count bottles) because they contain a harmful nitrosamine impurity above safe levels. This could lead to health risks if taken without proper medical supervision.
The tablets contain a nitrosamine impurity (N-Nitroso-Cinacalcet) that exceeds safe limits. This chemical can potentially cause health issues when taken, especially in people with kidney problems or those on calcium treatments.
People prescribed Cinacalcet tablets for high calcium levels who own the specific 90mg 30-count bottles manufactured by AvKARE in Pulaski, TN. Those with kidney issues or on calcium treatments are at higher risk.
Check for the 90mg Cinacalcet tablets in 30-count bottles with the lot number 44405, expiring December 31, 2024. The product is only available by prescription from AvKARE in Pulaski, TN.
Verify the product label for the lot number 44405 and expiration date of December 31, 2024.
The recall states the product contains a nitrosamine impurity above safe limits, so it is not safe to use without following the recall steps.
Look for the 90mg Cinacalcet tablets in 30-count bottles with lot number 44405, expiring December 31, 2024, manufactured by AvKARE in Pulaski, TN.
The recall does not specify a remedy, so contact your healthcare provider for guidance on next steps.
We’ve drafted a message you can send AvKARE to request your refund or repair — edit it as you like.
Subject: Recall D-0110-2025 — AvKARE AvKARE Hello, I own a AvKARE that is covered by recall D-0110-2025 from AvKARE. 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.
