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Recall Enforment Report D-0031-2025

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by ACCORD HEALTHCARE, INC., originally initiated on 10-10-2024 for the product 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. The product was recalled due to cgmp deviations: the presence of a nitrosamine impurity, n-nitroso-cinacalcet, above the acceptable daily intake (adi) limits.. The product was distributed nationwide and the recall is currently ongoing.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0031-202510-10-202411-06-2024Class IIN/ACinacalcet 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.CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.Ongoing
D-0032-202510-10-202411-06-2024Class IIN/ACinacalcet Tablets, 90 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-442-10, b) 90 Tablets per bottle, NDC: 16729-442-15, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad - 382 210, INDIA.CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.Ongoing
D-0030-202510-10-202411-06-2024Class IIN/ACinacalcet Tablets 30 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-440-10, b) 90 Tablets per bottle, NDC: 16729-440-15, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad - 382 210, INDIA.CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.Ongoing

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
16729-440Cinacalcet CinacalcetTablet, Film CoatedOralAccord Healthcare, Inc.Human Prescription Drug
16729-441Cinacalcet CinacalcetTablet, Film CoatedOralAccord Healthcare, Inc.Human Prescription Drug
16729-442Cinacalcet CinacalcetTablet, Film CoatedOralAccord Healthcare, Inc.Human Prescription Drug