Class II

Drug Recall: 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. · December 20, 2023

Reason for Recall

CGMP Deviations: N-Nitroso Desloratadine impurity result exceeded the acceptable intake limit.

Distribution

Product was distributed nationwide.

States Affected

NATIONWIDE

Quantity Affected

100=29,184 bottles; 500=2922 bottles

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0221-2024

Status: terminated

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Lupin Pharmaceuticals Inc. Drug Recall: 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. | SafeCheck