By Jack Phillips
Contributing Writer
Nearly 100,000 bottles of a type of drug used to treat chronic kidney disease and other conditions are being recalled due to possible carcinogens, according to a notice published by the Food and Drug Administration last week.
In three separate notices published on the FDA’s website, a combined 91,824 bottles of cinacalcet hydrochloride tablets in different strengths are being recalled due to the presence of a nitrosamine, N-nitroso-cinacalcet, found to be above the FDA’s acceptable daily intake levels.
The company that manufactured the cinacalcet hydrochloride tablets is Cipla USA, based in Warren, New Jersey. Cipla USA is owned by the global pharmaceutical company, Cipla Ltd., which is based in Mumbai, India.
The company voluntarily recalled the three drugs in November, according to the FDA notices.
The recalls were classified as Class II by the FDA on Dec. 9. A Class II recall is described by the agency as “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.”
Nitrosamines are a type of organic chemical that can be carcinogenic, or cancer-causing, in humans. They are often found in food products, drugs, water, and in the environment, according to the FDA.
“Nitrosamine impurities may increase the risk of cancer if people are exposed to them above acceptable levels and over long periods of time, but a person taking a drug that contains nitrosamines at-or-below the acceptable daily intake limits every day for 70 years is not expected to have an increased risk of cancer,” the FDA says on its website.
It adds that people who are taking prescription drugs that have possible nitrosamine impurities should not stop taking the medication and should speak to a health care provider if they want to seek an alternative.
Cinacalcet hydrochloride, which has the brand names Sensipar or Mimpara, is used to treat chronic kidney disease patients who are also on dialysis, people with high blood calcium levels, or people with primary hyperparathyroidism, according to the Mayo Clinic. The drug controls calcium levels in the blood.
Products Under Recall
The FDA notices say that three different strengths of the cinacalcet hydrochloride tablets are being recalled:
• 30-milligram tablets in bottles with a count of 30; an NDC of 69097-410-02; Lot 4PB0109 with an expiration of 1/31/2026 and Lot 5PB0172 with an expiration of 1/31/2027; 63,504 bottles are under recall.
• 60-milligram tablets in bottles with a count of 30; an NDC of 69097-411-02; Lot 5PB0164 with an expiration of 1/31/2027; 15,744 bottles are under recall.
• 90-milligram tablets in bottles with a count of 30; an NDC of 69097-412-02; Lot 5PB0183 with an expiration of 1/31/2027; 12,576 bottles are under recall.
According to the FDA notices, the recalls are still ongoing. No news release was issued by Cipla USA.
In November 2023, the FDA sent a warning letter to Cipla Ltd. after FDA officials inspected one of its plants in India earlier that year and found “significant violations.” A letter was sent by the FDA to Cipla in 2020 after an inspection at another India-based plant that also described violations at the time.
