Cinacalcet Tablets 60mg (Accord) – Nitrosamine Impurity (2024)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
ACCORD HEALTHCARE, INC.
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
a) Lot #: Expiry Date: M2204481 02/2025 M2212389 08/2025 M2214271 09/2025 M2215970 10/2025 M2216458 10/2025 b) Lot #: Expiry Date: M2212869 08/2025 M2216362 09/2025 M2215969 10/2025
ACCORD HEALTHCARE, INC. is recalling Cinacalcet Tablets, 60 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-441-10, b) 90 Tablets per b due to CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026