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Class II · ModerateActive recall

Cinacalcet

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numbera) 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
Where it was soldNationwide in the USA and PR
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byIntas Pharmaceuticals Limited, Ahmedabad - 382 210, INDIA foreign manufacturer
Brand nameCINACALCET
Generic nameCINACALCET
Active ingredient(s)CINACALCET HYDROCHLORIDE
Distributed by / forAccord Healthcare, Inc., Durham, NC 27703
NDC16729-441-10
Show the full FDA record
Full product labelCinacalcet 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.
Recalling firmACCORD HEALTHCARE, INC.
DistributionNationwide in the USA and PR
QuantityN/A
Recall initiated2024-10-10
Report date2024-11-06
Recall completed—
Recall numberD-0031-2025
ClassificationClass II
FDA statusOngoing
Origin on fileRaleigh NC United States

Related

Recent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.