Dr. Reddy's recalls 90mg Cinacalcet tablets with potential N-nitroso impurity above FDA limits. Rx-only medication may pose health risks. Check NDC 43598-369-30 and lot numbers for affected batches.
CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Dr. Reddy's is recalling 90mg Cinacalcet tablets due to a chemical impurity that may exceed FDA safety limits. This could pose health risks to people using the medication as prescribed.
The tablets contain N-nitroso impurities above the FDA's interim safety limit. This impurity could potentially cause health issues, though the exact risk level isn't specified in the recall notice.
People prescribed Cinacalcet tablets by a doctor who received the recalled product. Those with kidney disease or on dialysis are most at risk due to the medication's use.
Check for the product name 'Cinacalcet Tablets, 90 mg, 30-count bottle' with NDC 43598-369-30. Look for lot numbers T2201443 (expiring 03/2025) or T2300664 (expiring 12/2025).
Verify the NDC code 43598-369-30 and lot numbers T2201443 or T2300664 on the packaging.
The recall states there's a potential risk from the impurity, but the exact health impact isn't specified. Consult your doctor for advice.
Look for the NDC code 43598-369-30 and lot numbers T2201443 (expiring 03/2025) or T2300664 (expiring 12/2025) on the packaging.
The recall doesn't specify a remedy, so contact your doctor or pharmacist for guidance.
We’ve drafted a message you can send Dr. Reddy's to request your refund or repair — edit it as you like.
Subject: Recall D-0028-2025 — Dr. Reddy's Dr. Reddy's Hello, I own a Dr. Reddy's that is covered by recall D-0028-2025 from Dr. Reddy's. 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.
