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Recall Observatory FDA recall evidence

Drug product

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.

D-0221-2024

December 20, 2023

Class II

Product summary

Firm
Lupin Pharmaceuticals Inc.
Event
Event 93669
Status
Terminated
Classification
Class II
Quantity
100=29,184 bottles; 500=2922 bottles
Official record key
drug-enforcement:D-0221-2024

Official wording

Reason: CGMP Deviations: N-Nitroso Desloratadine impurity result exceeded the acceptable intake limit.

Code information: Lot # G201822, exp. date Jan 2024, 100 count G201823, exp. date Jan 2024, 100 count G201824, exp. date Jan 2024, 500 count

Distribution pattern: Product was distributed nationwide.

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    N-Nitroso Desloratadine impurity
  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations