FDA-Drug2024-01-17Class II
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.
Lupin Pharmaceuticals Inc.
Hazard
CGMP Deviations: N-Nitroso Desloratadine impurity result exceeded the acceptable intake limit.
Sold states
Product was distributed nationwide.
Affected count
100=29,184 bottles; 500=2922 bottles
Manufactured in
Harborplace Tower, 111 S Calvert St Fl 21st, Baltimore, MD, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0221-2024Don't want to check this manually?
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