Class II · Moderate risk
Sunitinib Malate Capsules
Labeling: Label Mix-Up
Sunitinib Malate Capsules
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Moisture Limits: Water (moisture) content above the approved product specifications.
Cause type: Failed specification
A physical or chemical test other than potency, dissolution, impurity or stability failed - pH, viscosity, appearance, tablet integrity, fill volume. A product outside its own specification may not perform as designed, even if the active ingredient is present. All failed specification recalls.
What was recalled
Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx only, Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0093-8199-28
Affected NDC
0093-8199-28
Compare with the code on your package — it is the most precise check available.
Drug: Sunitinib
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 |
|---|---|---|---|---|
| Sunitinib Malate NDC 00093-8199 |
12.5 mg/1 | Capsule Oral |
Teva Pharmaceuticals USA, Inc. | Rx |
- Recalling firm
- Teva Pharmaceuticals USA Inc
- NDC code
- 0093-8199-28
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0913-2023 · 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 Sunitinib recalls
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Class II · Moderate risk
Sunitinib Malate Capsules
Labeling: Label Mix-Up
Other recalls by Teva Pharmaceuticals USA Inc
All 2023 recalls
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