March 23, 2022
Pfizer is voluntarily recalling blood pressure medications that contain elevated levels of nitrosamine, a potential cancer-causing impurity.
Nitrosamines are commonly found in water and foods, including cured and grilled meats, dairy products and vegetables, the U.S. Food and Drug Administration says.
But Pfizer found nitrosamine levels to be above the acceptable daily intake level in several lots of Accuretic tablets and two generic versions of the drug.
"Everyone is exposed to some level of nitrosamines," Pfizer said. "These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time."
Six lots of Accuretic tablets, one lot of quinapril and hydrochlorothiazide tablets and four lots of quinapril HCl/ hydrochlorothiazide tablets are affected by the recall.
Accuretic and its generic versions are prescribed to people with hypertension to reduce the risk of cardiovascular events such as stroke and heart attacks.
As of Monday, Pfizer had not received any reports of adverse events related to the drugs. The specific nitrosamine found in the lots was N-nitroso-quinapril.
"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," it said.
The products affected are:
• Accuretic (quinapril HCl/hydrochlorothiazide) tablets, 10/12.5 mg
• Accuretic (quinapril HCl/hydrochlorothiazide) tablets, 20/12.5 mg
• Accuretic (quinapril HCl/hydrochlorothiazide) tablets, 20/25 mg
• quinapril and hydrochlorothiazide tablets, 20/25 mg
• quinapril HCl/hydrochlorothiazide tablets, 20/12.5 mg
• quinapril HCl/hydrochlorothiazide tablets, 20/25 mg
The recalled lots were distributed nationwide to wholesalers and distributors from November 2019 to March 2022. The lot numbers and expiration dates are:
• 0071-3112-23 FG5379 08/2024
• 0071-0222-23 EA6686 04/2022
• 0071-5212-23 FG5381 08/2024
• 0071-0220-23 EA6665 04/2022
• 0071-0220-23 CN0640 04/2022
• 0071-0223-23 ET6974 02/2023
Quinapril and hydrochlorothiazide
• 59762-5225-9 FE3714 02/2023
• 59762-0220-1 DN6931 03/2023
• 59762-0220-1 ED3904 03/2023
• 59762-0220-1 ED3905 03/2023
• 59762-0223-1 DP3414 02/2023
People taking these medications should consult with their health care providers or pharmacists to determine whether they've been given an affected batch, Pfizer advised.
They also can call (888) 843-0247 for instructions on how to return the products and get a refund.