Slate Run Pharmaceuticals recalls 30mg Cinacalcet Hydrochloride Tablets due to nitrosamine impurity exceeding safe levels. This may pose health risks with long-term use. Consumers should contact the manufacturer for details.
CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.
Slate Run Pharmaceuticals is recalling 30mg Cinacalcet Hydrochloride Tablets that may contain unsafe levels of nitrosamine. This impurity could lead to health risks with long-term use, so affected consumers should stop using the product and contact the manufacturer.
Nitrosamines are known carcinogens that can cause cancer when consumed in high amounts over time. The presence of nitrosamine above acceptable daily intake limits in these tablets may lead to health risks with long-term use.
People who have been prescribed Cinacalcet Hydrochloride Tablets 30 mg, 30-count bottles from Slate Run Pharmaceuticals. Those with kidney disease or on dialysis are at higher risk due to the medication's use.
Check for the product name 'Cinacalcet Hydrochloride Tablets 30 mg, 30-count bottle' with NDC 70436-007-04. The lot numbers 07711, 08900, and 08899 are also associated with this recall.
Immediately stop using the recalled Cinacalcet Hydrochloride Tablets if you have them.
The product contains nitrosamine impurities above acceptable daily intake limits, which may pose health risks with long-term use.
Look for the product name 'Cinacalcet Hydrochloride Tablets 30 mg, 30-count bottle' with NDC 70436-007-04 and lot numbers 07711, 08900, or 08899.
Stop using the product immediately and contact Slate Run Pharmaceuticals for further instructions.
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-0278-2025 — Slate Run Pharmaceuticals Slate Run Pharmaceuticals Hello, I own a Slate Run Pharmaceuticals that is covered by recall D-0278-2025 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.
