Accupril (Quinapril HCl Tablets) 10 mg, 90 Tablets Rx only NDC 0071-0530-23 Distributed by: Parke-Davis Division of Pfi
Summary
The FDA issued a Class II for Accupril (Quinapril HCl Tablets) 10 mg, 90 Tablets Rx only NDC 0071-0530-23 Dis by Pfizer Inc.. Reason: CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits..
Details
Source
Drug Recall
External ID
D-0872-2022
Action Date
2022-05-25
Status
Terminated
Category
drug
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/Code Info: Lot: DR9639 Exp. MAR 31 2023
Quantity Affected: 2079 bottles
Reason for Recall
CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.
Distribution
Nationwide and Puerto Rico
Type: Voluntary: Firm initiated
Recall Initiated: 2022-04-22
Company
New York, NY
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 44 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Pfizer Inc. has 45 FDA actions in our database, including 38 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Pfizer Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Pfizer Inc. have FDA actions?
Pfizer Inc. has 45 FDA actions in our database, including 38 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0872-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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