Hypertension Drugs Recalled

Pfizer Inc is recalling multiple lots of Accuretic (quinapril HCl/hydrochlorothiazide) tablets as well as generic quinapril and hydrochlorothiazide tablets and quinapril HCl/hydrochlorothiazide tablets because of the presence of a nitrosamine impurity, N-nitroso-quinapril, above the acceptable daily intake level. The recalls are included in the April 13, 2022, US Food and Drug Administration (FDA) Enforcement Report.

The recalls affect the following Accuretic products, which were made in Germany and distributed throughout the United States by Parke-Davis, a division of Pfizer:

• Accuretic 10 mg/12.5 mg, 90-tablet bottles (NDC 0071-0222-23), from lot EA6686 (Exp. 4/22);
• Accuretic 10 mg/12.5 mg, 90-tablet bottles (NDC 0071-3112-23), from lot FG5379 (Exp. 8/24);
• Accuretic 20 mg/12.5 mg, 90-tablet bottles (NDC 0071-0220-23), from lots EA6665 (Exp. 4/22) and CN0640 (Exp. 4/22);
•  Accuretic 20 mg/12.5 mg, 90-tablet bottles (NDC 0071-5212-23), from lot FG5381 (Exp. 8/24); and
• Accuretic 20 mg/25 mg, 90-tablet bottles (NDC 0071-0223-23), from lot ET6974 (Exp. 2/23).

Also recalled are the following generic products, made in Germany and distributed throughout the United States by Greenstone:

• quinapril HCl/hydrochlorothiazide tablets, 20 mg/12.5 mg, 90-tablet bottles (NDC 59762-0220-1), from lots DN6931, ED3904, and ED3905 (Exp. 3/23);
• quinapril HCl/hydrochlorothiazide tablets, 20 mg/25 mg, 90-tablet bottles (NDC 59762-0223-1), from lot DP3414 (Exp. 2/23); and
• quinapril and hydrochlorothiazide tablets, 20 mg/25 mg, 90-tablet bottles (NDC 59762-5225-9), from lot FE3714 (Exp. 2/23).

Pfizer voluntarily initiated the recalls March 21, 2022. On April 6, 2022, the FDA designated the recalls Class II, signaling use of affected products could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.

“To date, Pfizer is not aware of reports of adverse events that have been assessed to be related to this recall,” the company stated in a March 21, 2002, announcement. “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.”

Accuretic tablets, quinapril and hydrochlorothiazide tablets, and quinapril HCl/hydrochlorothiazide tablets are indicated for the treatment of hypertension.