Drug 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.
D-0287-2021
Product summary
- Event
- Event 87339
- Status
- Terminated
- Classification
- Class II
- Quantity
- a) 1350 bottles; b) 147 cartons
- Official record key
drug-enforcement:D-0287-2021
Official wording
Reason: Failed Dissolution Specifications
Code information: Lot #: a) H2000206, Exp 06/22; b) H2000138, Exp 06/22
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications