Dr. Reddy's Laboratories, Inc. recalls Imatinib Mesylate Tablets 100mg, packaged as a) 90-count bottles (NDC 43598-344-90); and b) For Institutional Use Only 3
Recalled March 3, 2021 · FDA recall D-0287-2021 · Dr. Reddy's Laboratories
Hazard
Failed Dissolution Specifications · FDA Class II
Units
a) 1350 bottles; b) 147 cartons
Sold at
Nationwide in the USA
Description
Failed Dissolution Specifications
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.
Manufacturer(s)
Dr. Reddy's Laboratories, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →