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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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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Pfizer Inc.: Dextran 40 in Dextrose Injection Recalled for Potential Bag Leaks

Agency Publication Date: October 9, 2019
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Summary

Pfizer is recalling approximately 17,832 bags of 10% LMD in 5% Dextrose Injection (Dextran 40 in Dextrose Injection, USP). This prescription medication, used to increase blood volume, is being recalled because the IV bags have the potential to leak. A leaking bag can compromise the sterility of the medicine, which may lead to serious infections if the contaminated fluid is administered to a patient. This recall affects Hospira brand products distributed nationwide in the United States and Puerto Rico.

Risk

The integrity of the IV bag is compromised by leaks, which allows bacteria or other contaminants to enter the sterile fluid. If this non-sterile solution is injected into a patient's bloodstream, it could result in life-threatening systemic infections or other severe health complications.

What You Should Do

  1. Check your medical supplies for 500 mL bags of 10% LMD in 5% Dextrose Injection (Dextran 40 in Dextrose Injection, USP) with NDC 0409-7418-13.
  2. Identify the affected products by looking for Lot Number 87-095-JT with an expiration date of 1MAR2020.
  3. If you have the affected product, stop using it immediately and do not administer it to patients.
  4. Contact your healthcare provider or pharmacist for guidance regarding alternative treatments and to report any adverse health effects.
  5. Return any unused or leaking bags to the place of purchase for a refund and contact Pfizer at 1-800-438-1985 for further instructions on returning the product.
  6. For additional questions or to report a complaint, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

๐Ÿ’ฐFull Refund

Healthcare provider consultation and product return.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: 10% LMD in 5% Dextrose Injection (Dextran 40 in Dextrose Injection, USP), 500 mL bags
Model:
NDC 0409-7418-13
Recall #: D-0136-2020
Lot Numbers:
87-095-JT (Exp. 1MAR2020)
Date Ranges: Expiration Date: 1MAR2020

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 83947
Status: Resolved
Manufacturer: Pfizer Inc.
Sold By: Hospira, Inc.; Hospitals; Clinics
Manufactured In: United States
Units Affected: 17832 bags
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 ยท 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.