Drug recall D-0221-2024
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.
Reason for recall
CGMP Deviations: N-Nitroso Desloratadine impurity result exceeded the acceptable intake limit.
Lots and codes
Lot # G201822, exp. date Jan 2024, 100 count G201823, exp. date Jan 2024, 100 count G201824, exp. date Jan 2024, 500 count
Recall details
- Recalling firm
- Lupin Pharmaceuticals Inc., Baltimore, MD
- Quantity
- 100=29,184 bottles; 500=2922 bottles
- Distribution
- Product was distributed nationwide.
- Type
- Voluntary: Firm initiated
- Recall initiated
- December 20, 2023
- Terminated
- April 4, 2025
Related products
- Desloratadine – drug information
- NDC 68180-153 Desloratadine · Desloratadine 5 mg/1 · Lupin Pharmaceuticals, Inc.