FDA Recalls Chronic Kidney Disease Medication Over Impurity Concerns

A medication that treats chronic kidney disease and other issues has been recalled across the U.S. due to potential impurities.

The drug, named Cinacalcet, is sold by the New Jersey-based Dr. Reddy's Laboratories, Inc. and manufactured in India.

The U.S. Food and Drug Administration (FDA) has announced that the recall was voluntarily initiated by the company, as a result of "CGMP [Current Good Manufacturing Practice] Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit."

Stock image of pills (main) and kidneys (inset). Cinacalcet tablets, which are used to treat chronic kidney disease, have been recalled due to potential impurities. ISTOCK / GETTY IMAGES PLUS

The recalled products are "Cinacalcet Tablets, 30 mg, 30-count bottle" with code NDC 43598-367-30. The affected batches include:

• Lot numbers T2200120, T2200121, T2200119, T2200116, T2200118, T2200117, with expiry date 11/2024
• Lot numbers T2200695, T2200694, T2200696, T2200697, with expiry date 01/2025;
• Lot numbers T2201426, T2201428, T2201432, T2201427, T2201430, T2201429, T2201431, with expiry date 03/2025;
• Lot numbers T2202743, T2202742, T2202741, & T2202740, with expiry date 06/2025;
• Lot numbrs T2203081, T2203079, T2203080, T2203082, T2203083 & T2203084, with expiry date 07/2025;
• Lot numbers T2300770, T2300771, T2300769, T2300766, T2300767 & T2300768, with expiry date 12/2025
• Lot numbers T2301663, T2301665, T2301662, T2301664, T2301667, T2301661, T2301666, T2301660, T2301658 & T2301659, with expiry date 02/2026
• Lot numbers T2304704, T2304703, T2304705, T2304706, with expiry date 08/2026
• Lot numbers T2400468, T2400469, T2400473 & T2400474, with expiry date 11/2026

285,126 bottles of the drug are included in the recall, and the FDA has classified the risk level of the recall as a "Class II".

The FDA defines a Class II recall as being issued when "a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote."

Newsweek has contacted Dr. Reddy's Laboratories for comment.

Cinacalcet is a medication used primarily to treat conditions related to abnormal calcium levels in the blood, such as secondary hyperparathyroidism—common in people with chronic kidney disease on dialysis—primary hyperparathyroidism, and parathyroid carcinoma.

Hyperparathyroidism causes the parathyroid glands to release too much parathyroid hormone, and as a result, calcium levels in the blood increase, potentially leading to issues like kidney stones, bone loss, and other complications.

Cinacalcet is a calcimimetic, meaning it mimics calcium in the body and reduces parathyroid hormone levels secretion. By lowering parathyroid hormone levels, it can help control calcium, benefiting both bone health and cardiovascular health in patients with chronic kidney disease.

N-nitroso cinacalcet is a type of impurity that can form during the manufacturing or storage of the drug cinacalcet. It belongs to a class of compounds called nitrosamines, which have recently become a concern in pharmaceuticals because they are considered potentially carcinogenic.

The FDA has established strict limits for nitrosamine impurities in drugs to minimize any potential cancer risk.

This batch of Cinacalcet was recalled due to the levels of N-nitroso Cinacalcet impurities being above the FDA-recommended interim limit.

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