Multi-event March 2022 FDA Recall Drug by Pfizer Inc.

This Multi-event Class II drug recall was voluntarily initiated by Pfizer Inc. on March 21, 2022 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-0758-2022 TERMINATED D-0760-2022 TERMINATED D-0755-2022 TERMINATED D-0759-2022 TERMINATED D-0756-2022 TERMINATED D-0757-2022 TERMINATED D-0761-2022 TERMINATED D-0754-2022 TERMINATED

Recall Number: D-0758-2022

Reason for Recall
CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
Initiated
03-21-2022
Reported
04-13-2022
Quantity
2442 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89864
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pfizer Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-28-2024
Product Description About Product Description
Full technical description of the product.
quinapril and hydrochlorothiazide tablets, 20 mg/25 mg*, 90 Tablets bottles, Rx Only, Distributed by: Greenstone, LLC, Peapack, NJ, 07977, Made in Germany, NDC 59762-5225-9

Batch or Lot Expiration Information

Lot# Lot FE3714; Exp. 02/2023

Recall Number: D-0760-2022

Reason for Recall
CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
Initiated
03-21-2022
Reported
04-13-2022
Quantity
1104 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89864
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pfizer Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-28-2024
Product Description About Product Description
Full technical description of the product.
quinapril HCl/hydrochlorothiazide tablets, 20 mg/25 mg*, 90 Tablets, Rx Only, Distributed by: Greenstone, LLC, Peapack, NJ, 07977, Made in Germany, NDC 59762-0223-1

Batch or Lot Expiration Information

Lot# Lot DP3414; Exp 02/2023

Recall Number: D-0755-2022

Reason for Recall
CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
Initiated
03-21-2022
Reported
04-13-2022
Quantity
160 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89864
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pfizer Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-28-2024
Product Description About Product Description
Full technical description of the product.
Accuretic (quinapril HCl/hydrochlorothiazide) Tablets 10 mg/12.5 mg 90 tablets bottle, Rx Only, Distributed by: Parke-Davis, Division of Pfizer Inc, NY, NY 10017, Made in Germany, NDC 0071-0222-23

Batch or Lot Expiration Information

Lot# Lot EA6686; Exp. 04/2022

Recall Number: D-0759-2022

Reason for Recall
CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
Initiated
03-21-2022
Reported
04-13-2022
Quantity
21108 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89864
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pfizer Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-28-2024
Product Description About Product Description
Full technical description of the product.
quinapril HCl/hydrochlorothiazide tablets, 20 mg/12.5 mg*, 90 Tablets bottles, Rx Only, Distributed by: Greenstone, LLC, Peapack, NJ, 07977, Made in Germany, NDC 59762-0220-1

Batch or Lot Expiration Information

Lot# Lots DN6931, ED3904 & ED3905; Exp. 03/2023

Recall Number: D-0756-2022

Reason for Recall
CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
Initiated
03-21-2022
Reported
04-13-2022
Quantity
1364 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89864
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pfizer Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-28-2024
Product Description About Product Description
Full technical description of the product.
Accuretic (quinapril HCl/hydrochlorothiazide) Tablets, 20 mg/12.5 mg, 90 tablets bottles, Rx Only Distributed by: Parke-Davis, Division of Pfizer Inc, NY, NY 10017, Made in Germany, NDC 0071-0220-23.

Batch or Lot Expiration Information

Lot# Lot EA6665, Exp Date 04/2022, Lot CN0640, Exp Date 04/2022

Recall Number: D-0757-2022

Reason for Recall
CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
Initiated
03-21-2022
Reported
04-13-2022
Quantity
265 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89864
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pfizer Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-28-2024
Product Description About Product Description
Full technical description of the product.
Accuretic (quinapril HCl/hydrochlorothiazide) Tablets, 20 mg/25 mg, 90 tablets bottles, Rx Only, Distributed by: Parke-Davis, Division of Pfizer Inc, NY, NY 10017, Made in Germany, NDC 0071-0223-23.

Batch or Lot Expiration Information

Lot# Lot ET6974; Exp. 02/2023

Recall Number: D-0761-2022

Reason for Recall
CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
Initiated
03-21-2022
Reported
04-13-2022
Quantity
195 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89864
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pfizer Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-28-2024
Product Description About Product Description
Full technical description of the product.
Accuretic (quinapril HCl/hydrochlorothiazide) tablets, 20 mg/12.5 mg*, 90 Tablets, Rx Only, Distributed by: Parke-Davis, Division of Pfizer Inc., NY. NY 10017, Made in Germany, NDC 0071-5212-23 .

Batch or Lot Expiration Information

Lot# Lot FG5381; Exp. 08/2024

Recall Number: D-0754-2022

Reason for Recall
CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
Initiated
03-21-2022
Reported
04-13-2022
Quantity
53 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89864
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pfizer Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-28-2024
Product Description About Product Description
Full technical description of the product.
Accuretic (quinapril HCl/hydrochlorothiazide) Tablets, 10 mg/12.5 mg*, 90 Tablets bottles, Rx Only, Distributed by: Parke-Davis, Division of Pfizer Inc, NY, NY 10017, Made in Germany, NDC 0071-3112-23.

Batch or Lot Expiration Information

Lot# Lot FG5379; Exp. 08/2024