Pfizer, the pharmaceutical company behind one of the Covid-19 vaccines, recalled certain lots of its high blood pressure medication for containing high levels of nitrosamines, which can lead to increased cancer risk.
The company announced a nationwide recall Monday and said it was pulling six lots of its Accuretic tablets.
It also pulled authorized generics distributed by its Greenstone subsidiary directly to patients — one lot of quinapril and hydrochlorothiazide tablets and four lots of quinapril HCl/ hydrochlorothiazide tablets.
Pfizer said nitrosamines are in food and water, including cured and grilled meats, dairy products and vegetables. But its medication was found to contain levels of nitrosamines that are higher than the acceptable daily intake level.
“Pfizer places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process,” the company said in a news release. “Pfizer has notified direct consignees by letter to arrange for return of any recalled product.”
The lots were distributed nationwide from November 2019 to this month. Pfizer said that it was not aware of any reports of adverse events related to the recall and that the Food and Drug Administration was aware of the situation.
“The products have a safety profile that has been established over 20 years of marketing authorization and through a robust clinical program,” the company said.
“Pfizer believes the benefit/risk profile of the products remains positive based on currently available data. Although long-term ingestion of N-nitroso-quinapril may be associated with a potential increased cancer risk in humans, there is no immediate risk to patients taking this medication.”
People who have been taking the medication should talk with their doctors about other options.
The presence of nitrosamines in blood pressure drugs has resulted in at least one other recall. In 2019, the FDA expanded a recall to include 32 lots of losartan, a drug sold by Macleods Pharmaceuticals, after they were found to contain unacceptable levels of the compounds.