D-0221-2024 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- January 17, 2024
- Initiation Date
- December 20, 2023
- Termination Date
- April 4, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 100=29,184 bottles; 500=2922 bottles
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.
Reason for Recall
CGMP Deviations: N-Nitroso Desloratadine impurity result exceeded the acceptable intake limit.
Distribution Pattern
Product was distributed nationwide.
Code Information
Lot # G201822, exp. date Jan 2024, 100 count G201823, exp. date Jan 2024, 100 count G201824, exp. date Jan 2024, 500 count