Jubilant Cadista Pharmaceuticals, Inc.: Drug Recall

Recall #D-0333-2021 · 04/01/2021

Class II: Risk

Recall Details

Recall Number: D-0333-2021
Classification: Class II
Product Type: Drug
Recalling Firm: Jubilant Cadista Pharmaceuticals, Inc.
Status: Terminated
Date Initiated: 04/01/2021
Location: Salisbury, MD, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: Lot #IT119008B - (4,128 Bottles); Lot #IT20001A - (3,984 Bottles); Lot #IT20002B - (4.080 Bottles)

Reason for Recall

Failed Dissolution Specifications

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.

Distribution Pattern

Nationwide in the USA

Other Recalls by Jubilant Cadista Pharmaceuticals, Inc.

Class III: Low Risk 12/27/2022

Subpotent Drug: Out of specification for assay at the 18-month stability timepoint.
Class II: Risk 07/18/2022

Failed Dissolution Specifications
Class II: Risk 07/18/2022

Failed dissolution specifications.
Class III: Low Risk 04/01/2022

Subpotent
Class I: Dangerous 03/08/2022

Labeling: Label mix-up: Incorrect label placed on product. Shipper cases labeled Meclizine Hydrochloride Tablets contain bottles incorrectly labeled as PredniSONE Tablets. The tablets in the bottles are Meclizine Hydrochloride

View all recalls by Jubilant Cadista Pharmaceuticals, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.