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.
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
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason 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.
Reason Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use.
Reason Lack of Assurance of Sterility
Reason Superpotent Drug: High out of specification assay value results for potency.
Reason Superpotent Drug: High out of specification assay value results for potency.
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