Quinapril Tablets USP, 20 mg (90 pack), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202
Summary
The FDA issued a Class II for Quinapril Tablets USP, 20 mg (90 pack), Rx Only, Manufactured for: Lupin Pharmac by Lupin Pharmaceuticals Inc.. Reason: CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit..
Details
Source
Drug Recall
External ID
D-0089-2023
Action Date
2022-12-28
Status
Terminated
Category
drug
Product Description
Quinapril Tablets USP, 20 mg (90 pack), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, by: Lupin Limited, Goa 403 722 India, NDC# 68180-558-09
Lot/Code Info: Lot #: G102929, Exp 04/2023
Quantity Affected: 23,736
Reason for Recall
CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
Distribution
Product was distributed by major distribution chains nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-12-07
Company
Baltimore, MD
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 21 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Lupin Pharmaceuticals Inc. has 49 FDA actions in our database, including 49 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 (Lupin Pharmaceuticals Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Lupin Pharmaceuticals Inc. have FDA actions?
Lupin Pharmaceuticals Inc. has 49 FDA actions in our database, including 49 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0089-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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