Desloratadine Tablets USP 5mg a) 100 count (NDC 68180-153-01) and b) 500 count (NDC 68180-153-02) bottles, Rx Only, Manu
Summary
The FDA issued a Class II for Desloratadine Tablets USP 5mg a) 100 count (NDC 68180-153-01) and b) 500 count ( by Lupin Pharmaceuticals Inc.. Reason: CGMP Deviations: N-Nitroso Desloratadine impurity result exceeded the acceptable intake limit..
Details
Source
Drug Recall
External ID
D-0221-2024
Action Date
2024-01-17
Status
Terminated
Category
drug
Product Description
Desloratadine Tablets USP 5mg a) 100 count (NDC 68180-153-01) and b) 500 count (NDC 68180-153-02) bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202.
Lot/Code Info: Lot # G201822, exp. date Jan 2024, 100 count G201823, exp. date Jan 2024, 100 count G201824, exp. date Jan 2024, 500 count
Quantity Affected: 100=29,184 bottles; 500=2922 bottles
Reason for Recall
CGMP Deviations: N-Nitroso Desloratadine impurity result exceeded the acceptable intake limit.
Distribution
Product was distributed nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-12-20
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 20 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-0221-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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