Irinotecan Hydrochloride Injection
FDA Recall NDC 0143-9702
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 3 recorded enforcement report(s) associated with Irinotecan Hydrochloride (NDC 0143-9702). 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
82,426 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 0143-9701-01
Batch or Lot Expiration Information
Lot# : AC0231, AC0235, exp. date 08/2021; AC0237, exp. date 09/2021
Affected Packages Involved in this Recall
0143-9702-01Product
0143-9701-01Product
Class II Terminated
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.
Sep 23, 2013
Nov 13, 2013
9813 vials
Recall Profile & Regulatory Data
Event ID
66447
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
West-Ward Pharmaceutical Corp.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Apr 05, 2016
Product Description
Irinotecan Hydrochloride Injection, 100 mg/5 mL (20 mg/mL), 1 x 5 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 0143-9701-01.
Batch or Lot Expiration Information
Lot# : AC0026, AC0027, Exp 10/14
Affected Packages Involved in this Recall
0143-9702-01Product
0143-9701-01Product
Class II Terminated
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.
Sep 23, 2013
Nov 13, 2013
9020 vials
Recall Profile & Regulatory Data
Event ID
66447
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
West-Ward Pharmaceutical Corp.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Apr 05, 2016
Product Description
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.
Batch or Lot Expiration Information
Lot# : AC0020, Exp 03/14; AC0023, AC0025, Exp 08/14
Affected Packages Involved in this Recall
0143-9702-01Product
0143-9701-01Product
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.
