Pfizer recalls blood pressure medication due to potential carcinogens

Pfizer mentions voluntary Accuretic as well as two generics that are used to treat hypertension due to an increased level of a toxin that can cause cancer.

Pfizer recalls six batches of Accuretic, one batch of quinapril and hydrochlorothiazide tablets and four batches of quinapril HCl / hydrochlorothiazide tablets. The generic drugs are distributed by Greenstone.

According to an announcement with the US Food and Drug Administration, the drugs have a level of nitrosamine above the acceptable daily intake level.

“Nitrosamines are common in water and food, including cured and grilled meats, dairy products and vegetables. Everyone is exposed to a level of nitrosamines.

These toxins can increase the risk of cancer if people are exposed to them at acceptable levels over a long period of time.

Pfizer said there was no “direct” risk to people taking the medication.

“The products have a security profile that has been established over 20 years of marketing authorization and through a robust clinical program. To date, Pfizer is unaware of reports of adverse events that have been assessed in connection with this recall.

Pfizer believes that the benefit / risk profile of the products remains positive based on currently available data. Although long-term use of N-nitroso-quinapril is associated with a potentially increased risk of cancer in humans, there is no immediate risk for patients taking this medicine. Patients currently taking the products should consult with their physician about alternative treatment options.

The drugs were distributed nationwide to wholesalers and distributors in the United States and Puerto Rico from November 2019 to March 2022.

The remedies available are:

• Accuretic, 10 / 12.5 mg, NDC number 0071-3112-23, lot number FG5379, runs August 2024.
• Accuretic, 10 / 12.5 mg, NDC number 0071-0222-23, Lot number EA6686, expires April 2022.
• Accuretic, 20 / 12.5 mg, NDC number 0071-5212-23, lot number FG5381, runs August 2024.
• Accuretic, 20 / 12.5 mg, NDC number 0071-0220-23, Lot number EA6665, expires April 2022.
• Accuretic, 20 / 12.5 mg, NDC number 0071-0220-23, lot number CN0640, expires April 2022.
• Accuretic, 20/25 mg, NDC number 0071-0223-23, Lot number ET6974, expires February 2023.
• Greenstone Quinapril and Hydrochlorothiazide, 20/25 mg, NDC Number 59762-5225-9, Lot Number FE3714, Lives February 2023
• Greenstone quinapril HCl / Hydrochlorothiazide, 20 / 12.5 mg, NDC number 59762-0220-1, Lot number DN6931, expires March 2023.
• Greenstone quinapril HCl / Hydrochlorothiazide, 20 / 12.5 mg, NDC number 59762-0220-1, Lot number ED3904, expires March 2023.
• Greenstone Quinapril HCl / Hydrochlorothiazide, 20 / 12.5 mg, NDC number 59762-0220-1, Lot number ED3905, expires March 2023.
• Greenstone quinapril HCl / Hydrochlorothiazide, 20/25 mg, NDC number 59762-0223-1, Lot number DP3414, expires February 2023.

Pfizer said it has informed distributors to distribute the drugs.

People taking the medication should consult their doctor. For more information, patients can contact Sedgewick at 888-843-0247 between 8 a.m. and 5 p.m. ET, Monday through Friday.