Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Superpotent Drug: a recent review of the USP revealed that an incorrect calculation was used to determine the amount of irinotecan to use in formulation which will result in an assay higher than the labeled claim.
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, 40 mg/2 mL (20 mg/mL), 1 x 2 mL Single Dose Vial per carton, Rx only, Manufactured by: Thymoorgan Pharmazie GmbH, Schiffgraben 23, 38690 Vienenburg, Germany; Distributed by: West-Ward Pharmaceutical Corp., Eatontown, NJ 07724 USA, NDC 0143-9702-01.
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 00143-9702 |
20 mg/mL | Injection Intravenous |
Hikma Pharmaceuticals USA Inc. | 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.
Failed Tablet/Capsule Specifications: Discovery of an underweight tablet.
Failed Impurities/Degradation Specifications; 12 month stability testing (Expansion of RES #70548).
Failed Impurities/Degradation Specifications; 12 month stability testing.
Subpotency: Out of Specification (OOS) result at the 36 month routine stability time point.
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