Reported Mar 3, 2021 · Terminated

Imatinib Mesylate Tablets 100mg, packaged as a) 90-count bottles (NDC 43598-344-90); and b) For Institutional Use Only…

Dr. Reddy's Laboratories, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Dr. Reddy's Laboratories, Inc. · 107 College Rd E · Princeton, NJ · 08540-6623

Is this the product you have?

4 of 4 products

Products covered by this recall
#Product as published
1Imatinib Mesylate Tablets 100mg, packaged as a) 90-count bottles (NDC 43598-344-90)
2and b) For Institutional Use Only 30-count (3 x 10 unit-dose) tablets per carton (NDC 43598-344-31)
3Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540
4Made in India.
Lot codes and dates
    • Lot #: a) H2000206
    • Exp 06/22
    • b) H2000138
    • Exp 06/22
Amount recalled
a) 1350 bottles; b) 147 cartons

Where it was sold

  • Nationwide

Why it was recalled

Failed Dissolution Specifications

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Dec 21, 2022 · Data as of Sep 19, 6:38 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.