Class II · Moderate risk Terminated
Imatinib Mesylate Tablets 100mg
Reason Failed Dissolution Specifications
Imatinib Mesylate Tablet 400 mg NDC 60505-2901-03 30 days supply
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Processing Controls.
What was recalled
Imatinib Mesylate Tablet 400 mg NDC 60505-2901-03 30 days supply
- Recalling firm
- Kroger Specialty Pharmacy, Inc.
- NDC code
- 60505-2901-03
- Origin
- MS, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0789-2018
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Imatinib recalls
See all
Class II · Moderate risk Terminated
Imatinib Mesylate Tablets 400 mg
Reason CGMP Deviations
Class II · Moderate risk Terminated
Imatinib Mesylate Tablets 100 mg
Reason CGMP Deviations
Class II · Moderate risk Terminated
Imatinib Mesylate active pharmaceutical ingredient packaged in…
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
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