Irbesartan Tablet
FDA Recall NDC 59746-447
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Irbesartan (NDC 59746-447). A significant event, classified as Class II, was initiated on Jul 18, 2022 by Jubilant Cadista Pharmaceuticals Inc.. The reported reason for this action was: "Failed dissolution specifications."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Failed dissolution specifications.
Jul 18, 2022
Aug 03, 2022
9,600 bottles
Recall Profile & Regulatory Data
Event ID
90610
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Jubilant Cadista Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Termination Date
Nov 22, 2022
Product Description
Irbesartan Tablets, USP, 150mg, 90- count bottles, Rx only, Manufactured by: Jubilant Generics Ltd. Roorkee- 247661, India, Marketed by: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-448-90
Batch or Lot Expiration Information
Lot# : IB220023A, exp. date 08/2022
Affected Packages Involved in this Recall
59746-447-30Product
59746-447-90Product
59746-447-05Product
59746-448-30Product
59746-448-90Product
59746-448-05Product
59746-449-30Product
59746-449-90Product
59746-449-05Product
Class II Terminated
Failed Dissolution Specifications
Jul 18, 2022
Aug 03, 2022
28,560 bottles
Recall Profile & Regulatory Data
Event ID
90610
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Jubilant Cadista Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Termination Date
Nov 22, 2022
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
Batch or Lot Expiration Information
Lot# : IB120012A, IB120013A, IB120014A Exp. date 08/2022
Affected Packages Involved in this Recall
59746-447-30Product
59746-447-90Product
59746-447-05Product
59746-448-30Product
59746-448-90Product
59746-448-05Product
59746-449-30Product
59746-449-90Product
59746-449-05Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
