Itraconazole Capsules, 100 mg, 30-count bottles, Rx only, Manufactured by: Jubilant Generics Ltd....
FDA Recall #D-0333-2021 — Class II — April 1, 2021
Product Description
Itraconazole Capsules, 100 mg, 30-count bottles, Rx only, Manufactured by: Jubilant Generics Ltd., Roorkee - 247661, India; Marketed by: Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD 21801, NDC 59746-282-30.
Reason for Recall
Failed Dissolution Specifications
Recalling Firm
Jubilant Cadista Pharmaceuticals, Inc. — Salisbury, MD
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
Lot #IT119008B - (4,128 Bottles); Lot #IT20001A - (3,984 Bottles); Lot #IT20002B - (4.080 Bottles)
Distribution
Nationwide in the USA
Code Information
Lot #s: IT119008B, Exp 05/2021; IT120001A, IT120002A, Exp 12/2021
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated