FDA recall D-0287-2021

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.

Reason for recall

Failed Dissolution Specifications

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2021-02-17

Report date

2021-03-03

Termination date

2022-12-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0287-2021