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-0874-2022	04-22-2022	05-25-2022	Class II	8346 bottles	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	CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.	Ongoing
D-0873-2022	04-22-2022	05-25-2022	Class II	10,304 bottles	Accupril (Quinapril HCl Tablets) 20 mg, 90 Tablets, Rx only NDC 0071-0532-23 Distributed by: Parke-Davis Division of Pfizer Inc. NY, NY 10017	CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.	Ongoing
D-0872-2022	04-22-2022	05-25-2022	Class II	2079 bottles	Accupril (Quinapril HCl Tablets) 10 mg, 90 Tablets Rx only NDC 0071-0530-23 Distributed by: Parke-Davis Division of Pfizer Inc. NY, NY 10017	CGMP 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
0071-0527	Accupril	Quinapril Hydrochloride	Tablet, Film Coated	Oral	Parke-davis Div Of Pfizer Inc	Human Prescription Drug
0071-0530	Accupril	Quinapril Hydrochloride	Tablet, Film Coated	Oral	Parke-davis Div Of Pfizer Inc	Human Prescription Drug
0071-0532	Accupril	Quinapril Hydrochloride	Tablet, Film Coated	Oral	Parke-davis Div Of Pfizer Inc	Human Prescription Drug
0071-0535	Accupril	Quinapril Hydrochloride	Tablet, Film Coated	Oral	Parke-davis Div Of Pfizer Inc	Human Prescription Drug

Field Name	Field Value
Event ID	90064 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0874-2022 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide and Puerto Rico What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description	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
Reason For Recall	CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	8346 bottles Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	05-25-2022
Recall Initiation Date	04-22-2022 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Initial Firm Notification	Press Release Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Pfizer Inc.
Code Info	Lots: DX6031 Exp. MAR 31 2023; CK6260 Exp. MAY 31 2022 Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	0071-0527-23; 0071-0530-23; 0071-0530-40; 0071-0532-23; 0071-0532-40; 0071-0535-23; 0071-1205-23; 0071-1410-23; 0071-1620-23; 0071-1840-23
Status	Ongoing

Field Name	Field Value
Event ID	90064 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0873-2022 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide and Puerto Rico What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description	Accupril (Quinapril HCl Tablets) 20 mg, 90 Tablets, Rx only NDC 0071-0532-23 Distributed by: Parke-Davis Division of Pfizer Inc. NY, NY 10017
Reason For Recall	CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	10,304 bottles Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	05-25-2022
Recall Initiation Date	04-22-2022 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Initial Firm Notification	Press Release Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Pfizer Inc.
Code Info	Lots: DX8682 Exp. MAR 31 2023; DG1188 Exp. MAR 31 2022 Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	0071-0527-23; 0071-0530-23; 0071-0530-40; 0071-0532-23; 0071-0532-40; 0071-0535-23; 0071-1205-23; 0071-1410-23; 0071-1620-23; 0071-1840-23
Status	Ongoing

Field Name	Field Value
Event ID	90064 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0872-2022 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide and Puerto Rico What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description	Accupril (Quinapril HCl Tablets) 10 mg, 90 Tablets Rx only NDC 0071-0530-23 Distributed by: Parke-Davis Division of Pfizer Inc. NY, NY 10017
Reason For Recall	CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	2079 bottles Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	05-25-2022
Recall Initiation Date	04-22-2022 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Initial Firm Notification	Press Release Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Pfizer Inc.
Code Info	Lot: DR9639 Exp. MAR 31 2023 Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	0071-0527-23; 0071-0530-23; 0071-0530-40; 0071-0532-23; 0071-0532-40; 0071-0535-23; 0071-1205-23; 0071-1410-23; 0071-1620-23; 0071-1840-23
Status	Ongoing