Slate Run Pharmaceuticals recalls 60mg Cinac: Nitrosamine impurity exceeds safe limits. Rx-only tablets may pose health risks. Check NDC 70436-008-04 for affected lots.
CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.
Slate Run Pharmaceuticals is recalling 60mg Cinacalcet Hydrochloride Tablets (30-count) due to nitrosamine impurities exceeding safe levels. This could pose health risks if taken as prescribed.
Nitrosamines are known carcinogens that can form in some medications. The presence of nitrosamine impurities above acceptable daily intake limits in these tablets could increase cancer risk with long-term use.
People with a prescription for Cinacalcet Hydrochloride Tablets 60mg from Slate Run Pharmaceuticals. Those who have the specific NDC 70436-008-04 lot number are most at risk.
Check for the product name 'Cinacalcet Hydrochloride Tablets 60 mg, 30-count bottle' with NDC code 70436-008-04 and lot number 109797. This product was distributed by Slate Run Pharmaceuticals in Columbus, Ohio.
Verify the NDC code 70436-008-04 and lot number 109797 on the product label.
The recall record states nitrosamine impurities exceed safe limits, but does not specify if the product is safe to take. Consult your healthcare provider for advice.
Look for the NDC code 70436-008-04 and lot number 109797 on the product label. This product was distributed by Slate Run Pharmaceuticals in Columbus, Ohio.
The recall record does not specify a remedy, so contact your healthcare provider for guidance.
We’ve drafted a message you can send Slate Run Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0279-2025 — Slate Run Pharmaceuticals Slate Run Pharmaceuticals Hello, I own a Slate Run Pharmaceuticals that is covered by recall D-0279-2025 from Slate Run Pharmaceuticals. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
