Blood pressure tablets recalled due to high levels of nitrosamine

The recall relates to Accuretic (quinapril HCl/hydrochlorothiazide) tablets distributed by Pfizer as well as two authorised generics distributed by Greenstone (quinapril and hydrochlorothiazide and quinapril HCl/ hydrochlorothiazide) to the patient (consumer/user) level in the US, due to the presence of a nitrosamine, N-nitroso-quinapril, above the acceptable daily intake (ADI) level. Pfizer will recall six lots of Accuretic tablets, one lot of quinapril and hydrochlorothiazide tablets and four lots of quinapril HCl/ hydrochlorothiazide tablets.

Nitrosamines are common in water and foods such as cured and grilled meats, dairy products and vegetables. Everyone is exposed to some levels of nitrosamines, but it is believed these impurities may increase the risk of cancer if people are exposed to above-acceptable levels over long periods of time.

The affected products are indicated for the treatment of hypertension. 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 authorisation and through a robust clinical programme. To date, Pfizer reports it is not aware of any adverse events that have been assessed to be related to this recall. 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. Patients currently taking the products should consult with their doctor about alternative treatment options.

The NDC, Lot Number, Expiration Date and Configuration details for these products are below. The product lots were distributed nationwide to wholesalers and distributors in the US and Puerto Rico from November 2019 to March 2022.

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

Pfizer has notified direct consignees by letter to arrange for return of any recalled product.

Wholesalers and distributors with existing inventory of the lots listed above are advised to halt use and distribution, and quarantine the product immediately.

In the event of further distribution of the recalled product, businesses should notify any accounts or additional locations that may have received the recalled product.

Pfizer has advised that patients taking this product should consult with their healthcare provider or pharmacy to determine if they have the affected product. Patients with the affected product should contact Sedgwick at 888-843-0247 (Mon-Fri 8:00 am – 5:00 pm ET) for instructions on how to return their product and obtain reimbursement for their cost.

This recall is being conducted with the knowledge of the US Food and Drug Administration.