AvKARE recalls 30mg Cinacalcet tablets with 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 30-mg Cinacalcet tablets that contain a nitrosamine impurity above safe levels. This could lead to health risks if taken without proper safety checks.
The tablets contain a nitrosamine impurity that exceeds safe limits. This impurity could potentially cause health risks when taken as directed, though the exact risk level is not clearly specified in the recall notice.
People with prescriptions for Cinacalcet tablets from AvKARE in Pulaski, TN, especially those using the medication for high calcium levels. Those with the specific lot numbers listed are most at risk.
Check for the product name 'Cinacalcet Tablets, 30 mg, 30-count bottle' with the lot numbers 44378, 44597, or 45804. These were manufactured for AvKARE in Pulaski, TN and expire December 31, 2024.
Verify the lot number and expiration date on the packaging to confirm if your tablets are part of the recall.
The recall states the tablets contain a nitrosamine impurity above safe limits, but does not specify if they are safe to use. The official notice does not provide details on whether the product is safe.
The recall does not specify a remedy, so the official notice does not state what action to take.
Check the lot number on the packaging; recalled lots are 44378, 44597, or 45804, manufactured for AvKARE in Pulaski, TN.
We’ve drafted a message you can send AvKARE to request your refund or repair — edit it as you like.
Subject: Recall D-0108-2025 — AvKARE AvKARE Hello, I own a AvKARE that is covered by recall D-0108-2025 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.
