Reported Mar 26, 2025 · Completed
Cinacalcet Hydrochloride Tablets 60 mg, 30-count bottle, Rx only, Distr. by: Slate Run Pharma., LLC, Columbus, Ohio…
Slate Run Pharmaceuticals
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: Slate Run Pharmaceuticals · 277 W Nationwide Blvd Ste 260 · Columbus, OH · 43215-0169
Is this the product you have?
- Cinacalcet Hydrochloride Tablets 60 mg, 30-count bottle, Rx only, Distr
- bySlate Run Pharma., LLC, Columbus, Ohio 43215, Mfg
- byPiramal Pharma Limited, Madhya Pradesh, India, NDC 70436-008-04
- Lot codes and dates
Lot # 109797Exp 11/2026
- Amount recalled
- 2,444 bottles
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
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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