Imatinib Mesylate Tablets 100mg recall: Failed Dissolution
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.
Why was Imatinib Mesylate Tablets 100mg recalled?
Failed Dissolution Specifications
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: a) H2000206, Exp 06/22; b) H2000138, Exp 06/22
- 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.
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- Quantity
- a) 1350 bottles; b) 147 cartons
- Distribution
- Nationwide in the USA
- Recall date
- March 3, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)