February 2021 FDA Recall Imatinib by Dr. Reddy's Laboratories, Inc.
D-0287-2021 - Failed Dissolution Specifications

This Class II drug recall was voluntarily initiated by Dr. Reddy's Laboratories, Inc. on February 17, 2021 for the product Imatinib. 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-0287-2021

Reason for Recall
Failed Dissolution Specifications
Initiated
02-17-2021
Reported
03-03-2021
Quantity
a) 1350 bottles; b) 147 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87339
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.
Dr. Reddy's Laboratories, 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.
12-21-2022
Product Description About Product Description
Full technical description of the product.
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

43598-344-30 Imatinib
43598-344-90 Imatinib
43598-344-10 Imatinib
43598-344-31 Imatinib
43598-345-30 Imatinib
43598-345-90 Imatinib
43598-345-05 Imatinib
43598-345-31 Imatinib