Imatinib Tablet
FDA Recall NDC 43598-345
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Imatinib (NDC 43598-345). A significant event, classified as Class II, was initiated on Feb 17, 2021 by Dr.reddy's Laboratories 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
Feb 17, 2021
Mar 03, 2021
a) 1350 bottles; b) 147 cartons
Recall Profile & Regulatory Data
Event ID
87339
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Dec 21, 2022
Product Description
Imatinib Mesylate Tablets 100mg, packaged as a) 90-count bottles (NDC 43598-344-90); and b) For Institutional Use Only 30-count (3 x 10 unit-dose) tablets per carton (NDC 43598-344-31); Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540; Made in India.
Batch or Lot Expiration Information
Lot# : a) H2000206, Exp 06/22; b) H2000138, Exp 06/22
Affected Packages Involved in this Recall
43598-344-30Product
43598-344-90Product
43598-344-10Product
43598-344-31Product
43598-345-30Product
43598-345-90Product
43598-345-05Product
43598-345-31Product
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.
