Why it was recalled
Failed Dissolution Specifications
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.
Lot numbers, UPCs & expiration codes
Lot #: a) H2000206, Exp 06/22; b) H2000138, Exp 06/22
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0287-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 17, 2021
- FDA report date
- Mar 3, 2021
- Quantity
- a) 1350 bottles; b) 147 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-0287-2021, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 87339
- Address
- 107 College Rd E
- Code information
- Lot #: a) H2000206, Exp 06/22; b) H2000138, Exp 06/22
- Postal code
- 08540-6623
- Report date
- Mar 3, 2021
- Product type
- Drugs
- Recall number
- D-0287-2021
- Classification
- Class II
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- Product quantity
- a) 1350 bottles; b) 147 cartons
- Termination date
- Dec 21, 2022
- Reason for recall
- Failed Dissolution Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Feb 17, 2021
- Initial firm notification
- Letter
- Center classification date
- Feb 24, 2021