Class II · Moderate risk
Imatinib Mesylate Tablets 100mg
Failed Dissolution Specifications
Imatinib Mesylate Tablets 400 mg
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
Imatinib Mesylate Tablets 400 mg, Rx Only, 30-count Bottle, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharmaceuticals Inc., Manalapan, NJ 07726, NDC 72485-203-30.
Affected NDC
72485-0203-30
Compare with the code on your package — it is the most precise check available.
Drug: Imatinib
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Imatinib mesylate 400 mg imatinib mesylate NDC 72485-0203 |
400 mg/1 | Tablet, Film Coated Oral |
Armas Pharmaceuticals Inc. | Rx |
- Recalling firm
- Shilpa Medicare Limited
- NDC code
- 72485-203-30
- Origin
- N/A, India
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0125-2021 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Imatinib recalls
See all
Class II · Moderate risk
Imatinib Mesylate Tablets 100 mg
CGMP Deviations
Class II · Moderate risk
Imatinib Mesylate Tablet 400 mg NDC 60505-2901-03 30 days supply
Lack of Processing Controls.
Class II · Moderate risk
Imatinib Mesylate active pharmaceutical ingredient packaged in…
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.
Other recalls by Shilpa Medicare Limited
All 2020 recalls
Class II · Moderate risk
Pemrydi Rtu
Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials
Class II · Moderate risk
Pemrydi Rtu
Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials
Class II · Moderate risk
Docetaxel Injection USP 160 mg/8mL
CGMP Deviations
Class II · Moderate risk
Imatinib Mesylate Tablets 100 mg
CGMP Deviations
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