Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Cinacalcet Tablets 30 mg Recalled by ACCORD HEALTHCARE, INC. Due to CGMP Deviations: the presence of a nitrosamine impurity,...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact ACCORD HEALTHCARE, INC. directly.
Affected Products
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.
Quantity: N/A
Why Was This Recalled?
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About ACCORD HEALTHCARE, INC.
ACCORD HEALTHCARE, INC. has 17 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report