ACCORD HEALTHCARE, INC. 2024-11-06 Health serious FDA
Health · FDA · Recall #FDA-D-0032-2025
Cinacalcet Tablets, 90 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-442-10, b) 90… Recall
Issued November 6, 2024 · ACCORD HEALTHCARE, INC.
In November 2024, ACCORD HEALTHCARE, INC. recalled the Cinacalcet Tablets, 90 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-442-10, b) 90…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
What you should do
- 1 Stop using Cinacalcet Tablets, 90 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-442-10, b) 90… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact ACCORD HEALTHCARE, INC. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- ACCORD HEALTHCARE, INC.
- Category
- Health
- Recall date
- November 6, 2024
- Units affected
- Not reported
- Sold at
- Nationwide in the USA and PR
- Recall number
- FDA-D-0032-2025
- Made in
- United States
- Issuing agency
- FDA
In context
- ACCORD HEALTHCARE, INC. has 6 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.