Reported Nov 6, 2024 · Ongoing
Cinacalcet Tablets 30 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-440-10, b) 90 Tablets per bottle, NDC:…
Accord Healthcare, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: ACCORD HEALTHCARE, INC. · 8041 Arco Corporate Dr Ste 200 · Raleigh, NC · 27617-2010
Is this the product you have?
Cinacalcet Tablets 30 mgRx Onlya) 30 Tablets per bottle
- NDC
16729-440-10b) 90 Tablets per bottle
- NDC16729-440-15
- Manufactured forAccord Healthcare, Inc., Durham, NC 27703
- Manufactured byIntas Pharmaceuticals Limited, Ahmedabad - 382 210, INDIA
- Lot codes and dates
- a) Lot #:
- Expiry Dateb) Lot #:
M211819011/2024M220109111/2024M220624111/2024M220645104/2025M220867406/2025M221385008/2025M221522109/2025M221623611/2025M221709811/2025M230066411/2025
- Expiry Date
M221080806/2025M221221208/2025M221443509/2025M221709711/2025M230192101/2026
- Amount recalled
- N/A
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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