Recalls / Class II
Class IID-0287-2021
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.
- Brand name
- Imatinib
- Generic name
- Imatinib
- Active ingredient
- Imatinib Mesylate
- Route
- Oral
- NDCs
- 43598-344, 43598-345
- FDA application
- ANDA206547
- Affected lot / code info
- Lot #: a) H2000206, Exp 06/22; b) H2000138, Exp 06/22
Why it was recalled
Failed Dissolution Specifications
Recalling firm
- Firm
- Dr. Reddy's Laboratories, Inc.
- Manufacturer
- Dr.Reddy's Laboratories Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 107 College Rd E, N/A, Princeton, New Jersey 08540-6623
Distribution
- Quantity
- a) 1350 bottles; b) 147 cartons
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2021-02-17
- FDA classified
- 2021-02-24
- Posted by FDA
- 2021-03-03
- Terminated
- 2022-12-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0287-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.