Recall of IV Cancer Medication Due to Glass Particles - MedWaste Management Recall of IV Cancer Medication Due to Glass Particles - MedWaste Management

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FDA Bleomycin Recall

Recall of IV Cancer Medication Due to Glass Particles

The FDA has announced an immediate recall of one lot of Bleomycin, an IV medication used to treat patients with cancer. The drug’s manufacturer, Hospira, Inc. (a Pfizer company), initiated the voluntary recall after a customer reported glass particles within the drug. These particles are extremely dangerous and pose serious health threats for those who are treated with the drug.

As of the writing of this notice, no adverse events related to the particulate have yet been reported.

SUMMARY

Date of Recall:

Announced: December 21, 2023

Public Notification: December 22, 2023

Name(s) of Drug:

Bleomycin for Injection, USP 15 Units Single Dose ONCO-TAIN™ Glass Fliptop Vial

Company Name:

Hospira, Inc. (a Pfizer company)

Brand Name:

No brand name

Drug Indication:

Squamous Cell Carcinoma

Hodgkin’s disease

Non-Hodgkin’s Lymphoma

Testicular Cancer

Malignant Pleural Effusion

Recall Bleomycin Glass Particles

Product Description

Health systems nationwide received distributions of the intravenous medication. The drug is packaged in a glass vial with a light blue flip-top. The drug name is printed on the front over a brown bar. Fifteen units are contained per vial.

Reason for Recall

A customer reported the presence of particulate matter to the manufacturer, who initiated an immediate recall.

Impacts

Patients who receive an intravenous injection of glass particulate matter containing drug may experience serious adverse health effects, including:

  • Injection site pain
  • Vein Inflammation
  • Blood clots
  • Stroke
  • Death

Lot Information

All wholesalers, pharmacies, and medical institutions are urged to check their stock for the presence of the drug. Compare existing stock with the product information in the chart below. Remove any stock that matches the drug name, strength, vial size, NDC number, lot number, and expiration date from circulation. Follow the recall procedures listed below.

Product

NDC Lot Number Expiration Date Presentation

Count

Bleomycin for injection, USP, 15 Units Single-Dose ONCO-TAIN™ Glass Fliptop vial

 

61703-332-18 BL12206A 30 Jun 2024 15 units/vial lyophilized 1 vial per carton, 112 vials per case

FDA.gov

Have you found that medication in your stock is part of the recall? Here’s what you should do:

Health Systems

  1. Examine all inventory and remove stock affected by the recall immediately.
  2. Contact Sedgwick Inc. at 1 (800) 805-3093 for assistance.
  3. If you have additional questions, contact Pfizer Medical Information at 1 (800) 438-1985, option 3. They are available Monday-Friday from 9:00 a.m. to 5:00 p.m. ET. You may also contact them online at www.pfizermedinfo.com.
  4. Contact MedWaste Management for information and assistance with disposing of the recalled medication.

Wholesaler

  1. Examine all inventory and remove stock affected by the recall immediately.
  2. Contact Sedgwick Inc. at 1 (800) 805-3093 for assistance.
  3. If you have additional questions, contact Pfizer Medical Information at 1 (800) 438-1985, option 3. They are available Monday-Friday from 9:00 a.m. to 5:00 p.m. ET. You may also contact them online at www.pfizermedinfo.com.
  4. Contact MedWaste Management for information and assistance with disposing of the recalled medication.

 

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Tammy McKinney, Nurse Writer

 

Tammy McKinney, RN, creator of HelpfulHospiceNurse, is a healthcare writer and seasoned registered nurse. With experience in acute care, long-term care, rehabilitation, drug & alcohol, and hospice & palliative care, she combines her medical understanding with her love for writing to educate and inform the public on various health-related topics. You can view a snippet of her portfolio here or reach out to her directly on LinkedIn!

 


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