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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Drug
Medications & Supplements/Prescription Drugs

Bleomycin for Injection Recalled for Potential Glass Particulates

Agency Publication Date: January 25, 2024
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Summary

Pfizer is recalling 3,546 vials of Bleomycin for Injection, USP, 15 units per vial, due to the presence of glass particulate matter. This sterile injectable medication, distributed by Hospira, Inc., is used in the treatment of various cancers. Injecting a medication contaminated with glass fragments can cause serious health issues, including blood clots or inflammation of the blood vessels. Consumers who have questions or concerns about this recall should contact their healthcare provider or pharmacist.

Risk

The injection of glass particles into the bloodstream can lead to local irritation, inflammation, or serious systemic complications such as blood clots that may travel to vital organs like the heart, lungs, or brain. While no injuries have been reported, the manufacturer has classified this risk as critical due to the potential for severe health consequences.

What You Should Do

  1. This recall affects Bleomycin for Injection, USP, 15 units per vial, sold in single-dose glass fliptop vials with NDC number 61703-332-18.
  2. Check your inventory for lot number BL12206A with an expiration date of 06/30/2024.
  3. Stop using the recalled product immediately. Healthcare facilities and clinical providers should quarantine any remaining stock and contact the manufacturer or their distributor to arrange for a return.
  4. If you have health concerns or believe you have been administered this recalled medication, contact your healthcare provider or pharmacist immediately.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional information regarding this recall.

Your Remedy Options

📋Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Bleomycin for Injection, USP (15 units per vial)by Pfizer / Hospira
Variants: 15 units per vial, Single dose glass fliptop vial
Lot Numbers:
BL12206A (Exp 06/30/2024)
NDC:
61703-332-18

Distributed by Hospira, Inc., Lake Forest, IL 68045.

Product Images

: “Bleomycin for Injection, USP, 15 Units Single-Dose ONCO-TAIN™ Glass Fliptop Vial, NDC 61703-332-18”

: “Bleomycin for Injection, USP, 15 Units Single-Dose ONCO-TAIN™ Glass Fliptop Vial, NDC 61703-332-18”

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93693
Status: Active
Manufacturer: PFIZER
Sold By: Hospira, Inc.; Medical wholesalers; Hospitals; Infusion centers
Manufactured In: United States
Units Affected: 3,546 vials
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · FDA Press Release · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.