Lupin Pharmaceuticals Inc. recalls Desloratadine Tablets USP 5mg a) 100 count (NDC 68180-153-01) and b) 500 count (NDC 68180-153-02) bottles, Rx Only, Manu
Recalled January 17, 2024 · FDA recall D-0221-2024 · Lupin Pharmaceuticals
Hazard
CGMP Deviations: N-Nitroso Desloratadine impurity result exceeded the acceptable intake limit. · FDA Class II
Units
100=29,184 bottles; 500=2922 bottles
Sold at
Product was distributed nationwide.
Description
CGMP Deviations: N-Nitroso Desloratadine impurity result exceeded the acceptable intake limit.
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.
Manufacturer(s)
Lupin Pharmaceuticals Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →