Drug Enforcement D-0032-2025

CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.

Status

Ongoing

Classification

Class II

Report Date

November 6, 2024

Termination Date

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Product Information

Product description
Cinacalcet 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.
Product quantity
N/A
Reason for recall
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
Nationwide in the USA and PR

Location & Firm

Recalling firm
ACCORD HEALTHCARE, INC.
Address
8041 Arco Corporate Dr Ste 200, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-0032-2025
Event ID
95501
Recall initiation date
October 10, 2024
Center classification date
October 31, 2024
Code info
a) Lot #: Expiry Date: M2303264 01/2026 b) Lot #: Expiry Date: M2306979 04/2026
More code info
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