Ascend Labs pulls 10 lots of anticoagulant pills after testing flags carcinogens

Ascend Laboratories, a unit of Indian drugmaker Alkem Laboratories, has issued a voluntary recall of 10 lots of the anticoagulant dabigatran etcxilate in capsule form after finding higher than acceptable levels of the suspected carcinogen N-nitroso-dabigatran during routine testing.

The recalled lots cover 75-mg and 150-mg doses of the drug, the company said in a release posted on the FDA’s website. To date, there have been no reports of adverse events related to the recalled drugs, the company said.

The company shipped the lots to wholesalers, distributors and retailers across the U.S. between June 2022 and October 2022.

Biopharma manufacturers large and small have been battling the presence of nitrosamine impurities over the last several years. 

For instance, last August, Merck found the potential cancer agent Nitroso-STG-19, also known as NTTP,  in certain samples of its Type 2 diabetes blockbuster Januvia, which generated $5.3 billion in 2021 and ranked as Merck’s third best-selling product.

And in March of last year, Pfizer Canada recalled all lots of the blood pressure drug Accuretic because of the presence of higher-than-allowed levels of a type of nitrosamine called N-nitroso-quinapril. The move by Pfizer came just days after the company said it was recalling 15 lots of another blood pressure drug, Inderal, on similar nitrosamine impurity concerns.

At the same time Pfizer was issuing its recalls, Novartis’ Sandoz recalled 13 lots of oral orphenadrine citrate 100-mg extended-release tablets after testing flagged unacceptable levels of a potential carcinogen dubbed NMOA, or Nitroso-Orphenadrine.

Nitrosamines, which are also found in air, drinking water, dairy products, vegetables and cured and grilled meats, can cause cancer after long-term, high-level exposure.