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 08

FDA recall notice · announced March 3, 2021 · Dr. Reddy's Laboratories

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

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.

Reason for recall

Failed Dissolution Specifications

Notes

Distribution: Nationwide in the USA
Lot/code information: Lot #: a) H2000206, Exp 06/22; b) H2000138, Exp 06/22
Quantity: a) 1350 bottles; b) 147 cartons
Status: Terminated
Products in this recall event:
- 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, Distr (D-0287-2021)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.