Class II
Terminated
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.
- Company
- Lupin Pharmaceuticals Inc.
- Recall Initiated
- December 20, 2023
- Posted
- January 17, 2024
- Recall Number
- D-0221-2024
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 100=29,184 bottles; 500=2922 bottles
- Firm Location
- Baltimore, MD, United States
Reason for Recall
CGMP Deviations: N-Nitroso Desloratadine impurity result exceeded the acceptable intake limit.
Distribution
Product was distributed nationwide.
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
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