Irinotecan Hydrochloride Injection
FDA Recall NDC 0143-9583
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Irinotecan Hydrochloride (NDC 0143-9583). A significant event, classified as Class II, was initiated on Jun 11, 2020 by Hikma Pharmaceuticals Usa Inc.. The reported reason for this action was: "Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use.
Jun 11, 2020
Jun 24, 2020
17,998 vials
Recall Profile & Regulatory Data
Event ID
85831
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Hikma Pharmaceuticals USA Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Termination Date
Jun 10, 2021
Product Description
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 0143-9583-01
Batch or Lot Expiration Information
Lot# :AC0231A, exp. date 08/2021
Affected Packages Involved in this Recall
0143-9583-01Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
