Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use.
Cause type: Packaging defect
Failed child-resistant closures, leaks, cracked containers, or a defective delivery device. Packaging failures risk accidental exposure (especially to children) or product contamination. All packaging defect recalls.
Irinotecan HCL Injection, USP, 100mg/5mL, 5 mL vials, Rx only, Manufactured by: Thymoorgan Pharmazie GmbH, Shiffgraben 23, 38690 Golsar, Germany Distributed by: West-Word Pharmaceutical Corp. Eatontown, NJ 07724 USA, NDC 0143-9701-01
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 00143-9701 |
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.
Lack of Assurance of Sterility
Superpotent Drug: High out of specification assay value results for potency.
Superpotent Drug: High out of specification assay value results for potency.
Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).
This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.
Failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds
Labeling: Label Mix-up: a bag of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection was found inside an overwrap labeled Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL)
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