Antihistamine Recalled for Impurity

Lupin Pharmaceuticals Inc. is recalling more than 32,000 bottles of 100- and 500-count desloratadine tablets. According to the January 17, 2024, US Food and Drug Administration (FDA) Enforcement Report, an N-nitroso desloratadine impurity was detected that exceeded the acceptable intake limit.

The recall affects 5-mg desloratadine tablets in 100- (NDC 68180-153-01) and 500-count (NDC 68180-153-02) bottles from lots G201822 (Exp. 1/24), G201823 (Exp. 1/24), and G201824 (Exp. 1/24). The tablets were manufactured for Lupin Pharmaceuticals, Baltimore, Maryland, and were distributed throughout the United States.

Lupin Pharmaceuticals voluntarily initiated the recall December 20, 2023. On January 9, 2024, the FDA designated the recall Class II. Drugs affected by Class II recalls may cause temporary or medically reversible adverse health consequences if used. While remote, a possibility of serious harm also exists.

Desloratadine is a prescription antihistamine indicated for the relief of seasonal perennial allergic rhinitis in patients 12 years and older.