Desloratadine Tablet, Film Coated
FDA Recall NDC 68180-153
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Desloratadine (NDC 68180-153). A significant event, classified as Class II, was initiated on Dec 20, 2023 by Lupin Pharmaceuticals, Inc.. The reported reason for this action was: "CGMP Deviations: N-Nitroso Desloratadine impurity result exceeded the acceptable intake limit."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
CGMP Deviations: N-Nitroso Desloratadine impurity result exceeded the acceptable intake limit.
Dec 20, 2023
Jan 17, 2024
100=29,184 bottles; 500=2922 bottles
Recall Profile & Regulatory Data
Event ID
93669
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Lupin Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed nationwide.
Termination Date
Apr 04, 2025
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.
Batch or Lot Expiration Information
Lot# G201822, exp. date Jan 2024, 100 count G201823, exp. date Jan 2024, 100 count G201824, exp. date Jan 2024, 500 count
Affected Packages Involved in this Recall
68180-153-01Product
68180-153-03Product
68180-153-06Product
68180-153-02Product
68180-153-11Product
68180-153-12Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
