ACCORD HEALTHCARE, INC.: Drug Recall

Recall #D-0030-2025 · 10/10/2024

Class II: Risk

Recall Details

Recall Number: D-0030-2025
Classification: Class II
Product Type: Drug
Recalling Firm: ACCORD HEALTHCARE, INC.
Status: Ongoing
Date Initiated: 10/10/2024
Location: Raleigh, NC, United States
Voluntary/Mandated: Voluntary: Firm initiated
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.

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.

Distribution Pattern

Nationwide in the USA and PR

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Subpotent Drug: Assay below the approved specification
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Subpotent Drug: Assay below the approved specification

View all recalls by ACCORD HEALTHCARE, INC. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.