Hypertension Drug Recalled

Pfizer is recalling 5 lots of Accupril (quinapril HCl) tablets due to the presence of a nitrosamine, N-nitroso-quinapril, above acceptable limits, according to the May 25, 2022, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects the following products, which were distributed by the Parke-Davis division of Pfizer throughout the United States and in Puerto Rico:

• Accupril 10 mg, 90 tablets (NDC 0071-0530-23), from lot DR9639 (Exp. 3/31/23);
• Accupril 20 mg, 90 tablets (NDC 0071-0532-23), from lots DX8682 (Exp. 3/31/23) and  DG1188 (Exp. 5/31/22); and
•  Accupril 40 mg, 90 tablets (NDC 0071-0535-23), from lots DX6031 (Exp. 3/31/23) and CK6260 (Exp. 5/31/22).

Pfizer voluntarily initiated the recall April 22, 2022. On May 16, 2022, the FDA designated the recall Class II, signaling use of the tablets could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.

Accupril is a prescription medication indicated for the treatment of hypertension and as adjunctive therapy for the management of heart failure.