Class II · Moderate risk Terminated
Imatinib Mesylate Tablets 100mg, packaged as a) 90-count bottles (NDC 43598-344-90); and b) For Institutional Use Only 30-count…
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
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Class II · Moderate risk Terminated
Imatinib Mesylate Tablets 400 mg, Rx Only, 30-count Bottle, Manufactured by: Shilpa Medicare Limited, India, Distributed by…
Reason CGMP Deviations
Class II · Moderate risk Terminated
Imatinib Mesylate Tablets 100 mg, Rx Only, 90-count Bottle, Manufactured by: Shilpa Medicare Limited, India, Distributed by…
Reason CGMP Deviations
Class II · Moderate risk Terminated
Imatinib Mesylate active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184…
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…
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