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.
Reported: March 3, 2021 Initiated: February 17, 2021 #D-0287-2021
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
Details
- Recalling Firm
- Dr. Reddy's Laboratories, Inc.
- Units Affected
- a) 1350 bottles; b) 147 cartons
- Distribution
- Nationwide in the USA
- Location
- Princeton, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Dr. Reddy's Laboratories, Inc.. Units affected: a) 1350 bottles; b) 147 cartons.
Why was this product recalled? ▼
Failed Dissolution Specifications
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 3, 2021. Severity: Moderate. Recall number: D-0287-2021.
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