April 2021 FDA Recall Drug by Jubilant Cadista Pharmaceuticals, Inc.
D-0333-2021 - Failed Dissolution Specifications

This Class II drug recall was voluntarily initiated by Jubilant Cadista Pharmaceuticals, Inc. on April 1, 2021 for the product Drug. The FDA reported the reason for recall as failed dissolution specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0333-2021

Reason for Recall
Failed Dissolution Specifications
Initiated
04-01-2021
Reported
04-21-2021
Quantity
Lot #IT119008B - (4,128 Bottles); Lot #IT20001A - (3,984 Bottles); Lot #IT20002B - (4.080 Bottles)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87667
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Jubilant Cadista Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-28-2022
Product Description About Product Description
Full technical description of the product.
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.

Batch or Lot Expiration Information

Lot# s: IT119008B, Exp 05/2021; IT120001A, IT120002A, Exp 12/2021