Irinotecan Hydrochloride Injection
FDA Recall NDC 50742-402
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Irinotecan Hydrochloride (NDC 50742-402). A significant event, classified as Class II, was initiated on Jun 08, 2018 by Ingenus Pharmaceuticals, Llc. The reported reason for this action was: "Superpotent Drug: High out of specification assay value results for potency."
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
Superpotent Drug: High out of specification assay value results for potency.
Jun 08, 2018
Jul 11, 2018
14089 vials
Recall Profile & Regulatory Data
Event ID
80254
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Ingenus Pharmaceuticals Llc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
May 01, 2019
Product Description
Irinotecan Hydrochloride Injection, USP, 40 mg/2 mL (20 mg/mL), 1 x 2 mL Single Dose Vial, Rx Only, Manufactured for: Ingenius Pharmaceuticals, LLC, Orlando, FL 32839-6408; Manufactured by: Ingenius Pharmaceuticals, GmbH Ticino 6917, Switzerland, NDC 50742-401-02.
Batch or Lot Expiration Information
Lot# : 17034-2, 17035-2, 17036-2; Exp. 08/19
Affected Packages Involved in this Recall
50742-401-02Product
50742-402-05Product
Class II Terminated
Superpotent Drug: High out of specification assay value results for potency.
Jun 08, 2018
Jul 11, 2018
34964 vials
Recall Profile & Regulatory Data
Event ID
80254
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Ingenus Pharmaceuticals Llc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
May 01, 2019
Product Description
Irinotecan Hydrochloride Injection, USP, 100 mg/5 mL (20 mg/mL), 1 x 5 mL Single Dose Vial, Rx Only, Manufactured for: Ingenius Pharmaceuticals, LLC, Orlando, FL 32839-6408; Manufactured by: Ingenius Pharmaceuticals, GmbH Ticino 6917, Switzerland, NDC 50742-402-05.
Batch or Lot Expiration Information
Lot# : 17034-1, 17035-1, 17036-1; Exp. 08/19
Affected Packages Involved in this Recall
50742-401-02Product
50742-402-05Product
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.
