Bleomycin Injection, Powder, Lyophilized, For Solution
FDA Recall NDC 0143-9240
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 Bleomycin (NDC 0143-9240). A significant event, classified as Class III, was initiated on Aug 05, 2021 by Hikma Pharmaceuticals Usa Inc.. The reported reason for this action was: "Labeling: Not elsewhere classified: Mislabeling"
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 III Terminated
Labeling: Not elsewhere classified: Mislabeling
Aug 05, 2021
Sep 01, 2021
1,152 vials
Recall Profile & Regulatory Data
Event ID
88402
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Hikma Pharmaceuticals USA Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA nationwide
Termination Date
Jun 08, 2023
Product Description
Bleomycin for Injection, USP, packaged in 15 units per single dose vial, Rx only, Manufactured by Thymoorgan Pharmazie GmbH Schiffgraben 23, 38690 Gosfar, Germany Distributed by Hikma USA Inc. Berkeley Heights, NJ 07922, NDC 0143-9240-01
Batch or Lot Expiration Information
Lot# BL0018
Affected Packages Involved in this Recall
0143-9240-01Product
0143-9241-01Product
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.
