Pfizer Recalls Blood Pressure Drug Over 'Impurity' Concerns

Pfizer is voluntarily recalling certain hypertension medications because of the possible presence of impurities. The affected products were distributed across the U.S. and also in Puerto Rico.

Pfizer announced Monday that it recalled certain lots of Accuretic (quinapril HCl/hydrochlorothiazide), as well as two generics that were distributed by Greenstone: quinapril and hydrochlorothiazide and quinapril HCl/ hydrochlorothiazide.

The recall was initiated due to the presence of the nitrosamine N-nitroso-quinapril that are above the Acceptable Daily Intake (ADI) levels, the company said. This comes just weeks after Pfizer recalled Accuretic in Canada because of nitrosamine impurity.

Nitrosamines are compounds that people are actually exposed to everyday. They can be found in low levels in food, water and even meat and dairy products. However, they can also form in drugs during the manufacturing process. Nitrosamine impurities can increase people's cancer risk if they are exposed to it "above acceptable levels" over a long period of time, the U.S. Food and Drug Administration (FDA) explained.

"(B)ut 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," noted the FDA.

Pfizer has not received any reports of adverse events related to the issue so far.

"Pfizer believes the benefit/risk profile of the products remains positive based on currently available data," the company said. "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."

The affected products were distributed from November 2019 to March 2022. The specifications of the recalled items, including the lot numbers, national drug code, expiration dates and configuration details, as well as photos of the packaging, are available on Pfizer's website.

According to the agency, those who are using prescription medications that have potential nitrosamine impurities "should not stop taking their medications." They should contact their healthcare provider to determine if the product they're using is affected by the recall.

"Pfizer places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process," the company added.