Cipla USA, Inc. recalled 15,744 bottles of Cinacalcet Hydrochloride Tablets on November 14, 2025. The recall follows the discovery of a nitrosamine impurity exceeding acceptable daily intake limits. Consumers should stop using the product immediately and consult healthcare providers.
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Consumers and healthcare providers should stop using this product immediately. Contact Cipla USA, Inc. or your healthcare provider for guidance. Notification method: Letter
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Cinacalcet Hydrochloride Tablets are prescribed for managing conditions related to parathyroid hormone levels, particularly in patients with chronic kidney disease. They help regulate calcium levels in the body, making them essential for certain patients.
The presence of N-nitroso-cinacalcet in the tablets poses a health risk as it exceeds acceptable daily intake limits. This impurity can lead to serious health consequences if consumed regularly.
This recall is not part of a broader industry pattern.
Consumers may face health risks associated with the impurity in the recalled tablets. The urgency to stop use and seek alternatives may lead to disruptions in treatment for some patients.
The lot number and expiration date can typically be found on the label or bottom of the bottle.
Expect a refund or further instructions within 4-6 weeks following the recall notification.
Keep receipts, correspondence with the manufacturer, and any medical records related to your use of the affected product.
The recall involves Cinacalcet Hydrochloride Tablets, 60 mg, sold in 30-tablet bottles. The affected lot is Lot 5PB0164, which has an expiration date of January 31, 2027. The product was distributed nationwide in the United States.
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