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The pharmaceutical giant announced that it was recalling certain lots of the blood pressure drug Accuretic and two authorized cheaper versions of the drug due to the presence of elevated levels of a nitrosamine, an impurity that could cause cancer.
“Nitrosamines are common in water and foods, including cured and grilled meats, dairy products, and vegetables,” Pfizer officials announced. “Everyone is exposed to some level of nitrosamines. These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time.”
Though nitrosamines are common, the levels found in Accuretic tablets distributed by Pfizer as well as two authorized generics distributed by Greenstone are above the Acceptable Daily Intake (ADI) the company said, prompting the voluntary national recall.
“Pfizer believes the benefit/risk profile of the products remains positive based on currently available data," the company said in a press release. "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."
There have been no reports of any adverse reactions from consumers using the medication.
“These products are indicated for the treatment of hypertension,” officials said. "Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
“The products have a safety profile that has been established over 20 years of marketing authorization and through a robust clinical program.’
Check here for a list of the lot numbers of the drugs being recalled. The recalled items were distributed nationwide to wholesalers and distributors in the US and Puerto Rico between November 2019 to March 2022.
“Pfizer places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process. Pfizer has notified direct consignees by letter to arrange for the return of any recalled product,” the company said.
“Wholesalers and distributors with an existing inventory of the lots, listed in the table above, should stop use and distribution and quarantine the product immediately.”
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