US Drug Recall Register
Class II · Moderate risk Terminated Initiated Apr 22, 2022 (4 years ago)

Accupril

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.

What was recalled

Accupril (Quinapril HCl Tablets) 40 mg, 90 Tablets, Rx only NDC 0071-0535-23 Distributed by: Parke-Davis Division of Pfizer Inc. NY, NY 10017

Recalling firm
Pfizer Inc.
NDC code
0071-0535-23
Origin
NY, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0874-2022

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

Other Quinapril recalls

See all
Class II · Moderate risk Terminated

Quinapril Tablets USP

Reason CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.

Lupin Pharmaceuticals Inc. NDC 68180-558-09 D-0089-2023
Class II · Moderate risk Terminated

Quinapril Tablets USP

Reason CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.

Lupin Pharmaceuticals Inc. NDC 68180-554-09 D-0088-2023
Class II · Moderate risk Completed

Quinapril and Hydrochlorothiazide Tablets

Reason CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.

Aurobindo Pharma USA Inc. NDC 65862-162-90 D-0021-2023
Class II · Moderate risk Terminated

Accupril

Reason CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.

Pfizer Inc. NDC 0071-0532-23 D-0873-2022
Class II · Moderate risk Terminated

Accupril

Reason CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.

Pfizer Inc. NDC 0071-0530-23 D-0872-2022