Jubilant Cadista Pharmaceuticals, Inc.: Drug Recall

Recall #D-1294-2022 · 07/18/2022

Class II: Risk

Recall Details

Recall Number: D-1294-2022
Classification: Class II
Product Type: Drug
Recalling Firm: Jubilant Cadista Pharmaceuticals, Inc.
Status: Terminated
Date Initiated: 07/18/2022
Location: Salisbury, MD, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 28,560 bottles

Reason for Recall

Failed Dissolution Specifications

Product Description

Irbesartan Tablets, USP, 75 mg, 90- count bottle, Rx only, Manufactured by: Jubilant Generics Ltd. Roorkee- 247661, India, Marketed by: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-447-90

Distribution Pattern

Nationwide within the United States

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 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
Class III: Low Risk 08/20/2021

Subpotent

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.