April 22, 2021
Jubilant Cadista Pharmaceuticals Inc is recalling three lots of itraconazole capsules. According to the April 21, 2021, US Food and Drug Administration (FDA) Enforcement Report, the product failed to meet dissolution specifications during testing.
The recall affects 100-mg itraconazole capsules in 30-count bottles (NDC 59746-282-30) from lots IT119008B (Exp. 5/21), IT120001A (Exp. 12/21), and IT120002A (Exp. 12/21). The drug was manufactured by Jubilant Generics Ltd. Roorkee, India, marketed by Jubilant Cadista Pharmaceuticals, Salisbury, MD, and distributed throughout the United States.
Jubilant Cadista Pharmaceuticals voluntarily initiated the recall April 1, 2021. The FDA designated the recall Class II on April 12, 2021. The classification communicates use of the drug may cause temporary or medically reversible adverse health consequences or a remote possibility of serious harm.
Itraconazole is a prescription medication used to treat a variety of fungal infections.