Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Cinacalcet Tablets, 60 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-441-10, b) 90 Tablets per bottle, NDC: 16729-441-15, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad - 382 210, INDIA.
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
Reason cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
Reason cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
Reason CGMP Deviations
Reason CGMP Deviations
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