Medications & Supplements/Prescription Drugs

B. Braun Medical Inc: Heparin Sodium Injection Recalled Due to Subpotency Issues

Agency Publication Date: June 13, 2019

Summary

B. Braun Medical Inc. recalled 40,176 bags of Heparin Sodium (25,000 USP units per 250 mL) in 5% Dextrose Injection because the medication was found to be subpotent. Testing revealed that the drug's anti-factor IIa potency was lower than required by safety standards, which means the medication may not be as effective as necessary for patients. This recall affects the 250 mL EXCEL Container bags used in clinical settings.

Risk

Subpotent heparin may fail to prevent or treat blood clots effectively. This lack of full potency could lead to serious medical complications, such as a stroke, heart attack, or pulmonary embolism, as the medication is intended to ensure proper blood thinning.

What You Should Do

Identify the product by checking the label for Heparin Sodium 25,000 USP units per 250 mL (100 USP units per mL) in 5% Dextrose Injection in a 250 mL EXCEL Container bag (NDC 0264-9587-20).
Confirm if your product is affected by looking for Lot Number J7B259 with an expiration date of 31 Aug 2019.
Immediately contact your healthcare provider or pharmacist for guidance if you or a patient have been using this specific lot of medication.
Return any unused product to the pharmacy or place of purchase for a refund and to ensure the subpotent drug is removed from circulation.
For more information, you may contact B. Braun Medical Inc. at their facility located at 2525 Mcgaw Ave, Irvine, California, 92614-5841.
For additional consumer safety questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full 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: Heparin Sodium 25,000 USP units per 250 mL (100 USP units per mL) in 5% Dextrose Injection (250 mL)

Model:

NDC 0264-9587-20

Recall #: D-1343-2019

Lot Numbers:

J7B259 (Exp 31 Aug 2019)

Date Ranges: Exp 31 Aug 2019

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 83089

Status: Resolved

Manufacturer: B. Braun Medical Inc

Sold By: Hospitals; Pharmacies; Healthcare Providers

Manufactured In: United States, Spain

Units Affected: 40,176 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

What You Should Do

Identify the product by checking the label for Heparin Sodium 25,000 USP units per 250 mL (100 USP units per mL) in 5% Dextrose Injection in a 250 mL EXCEL Container bag (NDC 0264-9587-20).

Confirm if your product is affected by looking for Lot Number J7B259 with an expiration date of 31 Aug 2019.

Immediately contact your healthcare provider or pharmacist for guidance if you or a patient have been using this specific lot of medication.

Return any unused product to the pharmacy or place of purchase for a refund and to ensure the subpotent drug is removed from circulation.

For more information, you may contact B. Braun Medical Inc. at their facility located at 2525 Mcgaw Ave, Irvine, California, 92614-5841.

For additional consumer safety questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.