FDA-Drug2021-03-03Class II
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.
Dr. Reddy's Laboratories, Inc.
Hazard
Failed Dissolution Specifications
Sold states
Nationwide in the USA
Affected count
a) 1350 bottles; b) 147 cartons
Manufactured in
107 College Rd E, N/A, Princeton, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0287-2021Don't want to check this manually?
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