Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Superpotent Drug: High out of specification assay value results for potency.
Cause type: Wrong potency / content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.
Irinotecan Hydrochloride Injection, USP, 40 mg/2 mL (20 mg/mL), 1 x 2 mL Single Dose Vial, Rx Only, Manufactured for: Ingenius Pharmaceuticals, LLC, Orlando, FL 32839-6408; Manufactured by: Ingenius Pharmaceuticals, GmbH Ticino 6917, Switzerland, NDC 50742-401-02.
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 50742-0401 |
40 mg/2mL | Injection Intravenous |
Ingenus Pharmaceuticals, 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.
Out of specification for related substances (impurities).
CGMP Deviations
Crystallization: Presence of particulate matter identified as API crystallization
Defective Container: firm discovered samples stored horizontally as well as product quality complaints from customers for bottles leaking.
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