Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Crystallization: Active pharmaceutical ingredient is precipitating in product solution.
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.
IRINOTECAN HYDROCHLORIDE INJECTION, 40 mg/2 mL (20 mg/mL), 2 mL Single Dose Vial, Rx only, Manufactured for: APP Pharmaceuticals, LLC, Schaumburg, IL 60173, NDC 63323-193-02, UPC 3 63323 19302 7.
Compare with the code on your package — it is the most precise check available.
Drug: Irinotecan
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 |
|---|---|---|---|---|
| Irinotecan Hydrochloride NDC 63323-0193 |
20 mg/mL | Injection, Solution Intravenous |
Fresenius Kabi USA, LLC | Rx |
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.
CGMP Deviations: based on a Warning Letter received by the manufacturer of the recalled product for inadequate out-of specification investigations, complaint and the investigation conclusions.
Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use.
Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use.
Lack of Assurance of Sterility
Superpotent Drug: High out of specification assay value results for potency.
Labeling: Missing label
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