Recall Enforment Report D-0874-2022

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Pfizer Inc., originally initiated on 04-22-2022 for the product 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 The product was recalled due to cgmp deviations: contains n-nitrosoquinapril above the acceptable limits.. The product was distributed nationwide and the recall is currently ongoing.

Recall Enforcement Reports

Recall Number Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0874-202204-22-202205-25-2022Class II8346 bottlesAccupril (Quinapril HCl Tablets) 40 mg, 90 Tablets, Rx only NDC 0071-0535-23 Distributed by: Parke-Davis Division of Pfizer Inc. NY, NY 10017CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.Ongoing
D-0873-202204-22-202205-25-2022Class II10,304 bottlesAccupril (Quinapril HCl Tablets) 20 mg, 90 Tablets, Rx only NDC 0071-0532-23 Distributed by: Parke-Davis Division of Pfizer Inc. NY, NY 10017CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.Ongoing
D-0872-202204-22-202205-25-2022Class II2079 bottlesAccupril (Quinapril HCl Tablets) 10 mg, 90 Tablets Rx only NDC 0071-0530-23 Distributed by: Parke-Davis Division of Pfizer Inc. NY, NY 10017CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.Ongoing

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
0071-0527Accupril Quinapril HydrochlorideTablet, Film CoatedOralParke-davis Div Of Pfizer IncHuman Prescription Drug
0071-0530Accupril Quinapril HydrochlorideTablet, Film CoatedOralParke-davis Div Of Pfizer IncHuman Prescription Drug
0071-0532Accupril Quinapril HydrochlorideTablet, Film CoatedOralParke-davis Div Of Pfizer IncHuman Prescription Drug
0071-0535Accupril Quinapril HydrochlorideTablet, Film CoatedOralParke-davis Div Of Pfizer IncHuman Prescription Drug