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Class II: temporary or reversible health riskTerminated

Pfizer Accupril Recall

Accupril (Quinapril HCl Tablets) 10 mg, 90 Tablets Rx only NDC 0071-0530-23 Distribute…

Pfizer Inc. · New York, NY

Risk level
Class II
Reported by FDA
May 25, 2022
Recall ID
D-0872-2022
Check your lot numberHow we source this data

Summary

Pfizer recalled Accupril starting Apr 22, 2022. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0872-2022 on May 25, 2022. Reason: CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits. Status: Terminated.

Why it was recalled

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

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

Lot numbers, UPCs & expiration codes

Lot: DR9639 Exp. MAR 31 2023

Where it was sold

Nationwide and Puerto Rico

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0872-2022
Classification
Class II
Status
Terminated
Recall initiated
Apr 22, 2022
FDA report date
May 25, 2022
Quantity
2079 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Pfizer Inc.

Original FDA data

Every field from FDA enforcement report D-0872-2022, exactly as published.

Show all FDA fields
City
New York
State
NY
Status
Terminated
Country
United States
Event ID
90064
Address
235 East 42nd Street
Code information
Lot: DR9639 Exp. MAR 31 2023
Postal code
10017-5703
Report date
May 25, 2022
Product type
Drugs
Recall number
D-0872-2022
Classification
Class II
Recalling firm
Pfizer Inc.
Product quantity
2079 bottles
Termination date
Oct 5, 2023
Reason for recall
CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.
Voluntary / mandated
Voluntary: Firm initiated
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
Distribution pattern
Nationwide and Puerto Rico
Recall initiation date
Apr 22, 2022
Initial firm notification
Press Release
Center classification date
May 16, 2022

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0872-2022, published May 25, 2022. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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