D-0287-2021 Class II Terminated
FDA drug recall D-0287-2021 was initiated by Dr. Reddy's Laboratories, Inc. on February 17, 2021 and is designated Class II. Reason for recall: Failed Dissolution Specifications The recall status is terminated (terminated December 21, 2022). Affected quantity: a) 1350 bottles; b) 147 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- March 3, 2021
- Initiation Date
- February 17, 2021
- Termination Date
- December 21, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- a) 1350 bottles; b) 147 cartons
Product Description
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 Pattern
Nationwide in the USA
Code Information
Lot #: a) H2000206, Exp 06/22; b) H2000138, Exp 06/22