Medications & Supplements/Prescription Drugs

Pfizer Inc.: Magnesium Sulfate Bags Recalled Due to Potential Mislabeling with Heparin

Agency Publication Date: October 11, 2018

Summary

Pfizer Inc. is recalling 94,752 bags of Magnesium Sulfate in Water for Injection (0.325 mEq Mg++/mL) after a report that a bag of Heparin (an anticoagulant) was found incorrectly packed inside a case of Magnesium Sulfate. While the individual bag was correctly labeled as Heparin, its presence in a Magnesium Sulfate case could lead to a healthcare provider administering the wrong medication. This recall affects one specific lot of 500 mL single-dose bags distributed nationwide in the USA and Puerto Rico.

Risk

If a patient inadvertently receives Heparin instead of the intended Magnesium Sulfate, they may experience unintended blood thinning, which increases the risk of serious bleeding events or hemorrhaging. This poses a significant risk to patient safety in a clinical setting where precise medication administration is critical.

What You Should Do

Check your inventory for Magnesium Sulfate in Water for Injection (40 mg/mL, 20 g Total, 500 mL Single-Dose Container bags) with NDC 0409-6729-03.
Verify if your product matches Lot 87904FW with an expiration date of 1MAR2020.
Inspect cases specifically for any misplaced units of Heparin in 0.45% Sodium Chloride for Injection (NDC 0409-7651-03, Lot 87903FW) that may be inside the Magnesium Sulfate packaging.
If you identify affected products, stop using them immediately and quarantine the items to prevent administration to patients.
Contact your healthcare provider or pharmacist for guidance regarding any potential exposure, and return any unused product to the place of purchase for a refund.
Contact Pfizer Inc. at their New York headquarters or via the distributor Hospira, Inc. for further instructions on returning the product and obtaining a remedy.
For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

Full Refund

Product return and refund

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

Affected Products

Product: Magnesium Sulfate in Water for Injection (500 mL)

Model:

NDC 0409-6729-03

Lot Numbers:

87904FW (Exp. 1MAR2020)

Date Ranges: Expiration date 1MAR2020

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 81126

Status: Resolved

Manufacturer: Pfizer Inc.

Sold By: Hospira, Inc.; Healthcare facilities; Hospitals

Manufactured In: United States

Units Affected: 94,752 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 · 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.

Summary

Risk

What You Should Do

Check your inventory for Magnesium Sulfate in Water for Injection (40 mg/mL, 20 g Total, 500 mL Single-Dose Container bags) with NDC 0409-6729-03.

Verify if your product matches Lot 87904FW with an expiration date of 1MAR2020.

Inspect cases specifically for any misplaced units of Heparin in 0.45% Sodium Chloride for Injection (NDC 0409-7651-03, Lot 87903FW) that may be inside the Magnesium Sulfate packaging.

If you identify affected products, stop using them immediately and quarantine the items to prevent administration to patients.

Contact your healthcare provider or pharmacist for guidance regarding any potential exposure, and return any unused product to the place of purchase for a refund.

Contact Pfizer Inc. at their New York headquarters or via the distributor Hospira, Inc. for further instructions on returning the product and obtaining a remedy.

For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).