Drug Enforcement D-0030-2025

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 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.
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-0030-2025
Event ID
95501
Recall initiation date
October 10, 2024
Center classification date
October 31, 2024
Code info
a) Lot #: Expiry Date: M2118190 11/2024 M2201091 11/2024 M2206241 11/2024 M2206451 04/2025 M2208674 06/2025 M2213850 08/2025 M2215221 09/2025 M2216236 11/2025 M2217098 11/2025 M2300664 11/2025 b) Lot #: Expiry Date: M2210808 06/2025 M2212212 08/2025 M2214435 09/2025 M2217097 11/2025 M2301921 01/2026
More code info
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