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U.S. Department of Health and Human Services

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Recall -- Firm Press Release

 

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

 

B. Braun's Supplier Recall of Heparin API Prompts Voluntary Recall of Heparin Solutions

Scientific Protein Laboratories LLC (SPL) manufactures Heparin Sodium USP active pharmaceutical ingredient that is used by B. Braun Medical Inc. to produce Heparin Sodium in 5% Dextrose and 0.9% Sodium Chloride injection solution 

 

Contact:
Stephanie Euler, 908-276-4344 ext. 213
Susan Denby, 610-997-4856

 

FOR IMMEDIATE RELEASE --Irvine, CA -- March 21, 2008 --- B. Braun Medical Inc. was recently notified by its supplier, Scientific Protein Laboratories LLC (SPL) of a nationwide recall of Heparin Sodium USP active pharmaceutical ingredient (API). The voluntary recall affects the following 23 Finished Product (FP) lots manufactured and distributed by B. Braun Medical Inc. nationwide and to Canada.

B. Braun FP Lot #

B. Braun FP Material

Description

NDC Numbers

CAN DIN

J7D490

P5872

Heparin Sodium 25,000 Units in 5% Dextrose Injection (250mL)

0264-9587-20

N/A

J7C684

P5771

Heparin Sodium 25,000 Units in 5% Dextrose Injection (500mL)

0264-9577-10

N/A

J7D496

P5771

Heparin Sodium 25,000 Units in 5% Dextrose Injection (500mL)

0264-9577-10

N/A

J7C470

P5872

Heparin Sodium 25,000 Units in 5% Dextrose Injection (250mL)

0264-9587-20

N/A

J7D580

P5671-00

Heparin Sodium 20,000 Units in 5% Dextrose Injection (500mL)

N/A

02209713

J7E420

P5872-00

Heparin Sodium 25,000 Units in 5% Dextrose Injection (250mL)

N/A

02209721

J7C611

P8721

Heparin Sodium 1000 Units in 0.9% Sodium Chloride Injection (500mL)

0264-9872-10

01935933

J7C557

P8721

Heparin Sodium 1000 Units in 0.9% Sodium Chloride Injection (500mL)

0264-9872-10

01935933

J7C477

P8721

Heparin Sodium 1000 Units in 0.9% Sodium Chloride Injection (500mL)

0264-9872-10

01935933

J7C705

P8721

Heparin Sodium 1000 Units in 0.9% Sodium Chloride Injection (500mL)

0264-9872-10

01935933

J7D485

P8721

Heparin Sodium 1000 Units in 0.9% Sodium Chloride Injection (500mL)

0264-9872-10

01935933

J7E415

P8721

Heparin Sodium 1000 Units in 0.9% Sodium Chloride Injection (500mL)

0264-9872-10

01935933

J7E416

P8721

Heparin Sodium 1000 Units in 0.9% Sodium Chloride Injection (500mL)

0264-9872-10

01935933

J7E494

P5872

Heparin Sodium 25,000 Units in 5% Dextrose Injection (250mL)

0264-9587-20

N/A

J7E500

P5771

Heparin Sodium 25,000 Units in 5% Dextrose Injection (500mL)

0264-9577-10

N/A

J7E577

P5771-00

Heparin Sodium 25,000 Units in 5% Dextrose Injection (500mL)

N/A

01935941

J7E489

P8721

Heparin Sodium 1000 Units in 0.9% Sodium Chloride Injection (500mL)

0264-9872-10

01935933

J7N556

P5872

Heparin Sodium 25,000 Units in 5% Dextrose Injection (250mL)

0264-9587-20

N/A

J7P404

P5771

Heparin Sodium 25,000 Units in 5% Dextrose Injection (500mL)

0264-9577-10

N/A

J7N604

P5771

Heparin Sodium 25,000 Units in 5% Dextrose Injection (500mL)

0264-9577-10

N/A

J7P476

P5872

Heparin Sodium 25,000 Units in 5% Dextrose Injection (250mL)

0264-9587-20

N/A

J7N519

P8721

Heparin Sodium 1000 Units in 0.9% Sodium Chloride Injection (500mL)

0264-9872-10

01935933

J7N676

P8721

Heparin Sodium 1000 Units in 0.9% Sodium Chloride Injection (500mL)

0264-9872-10

01935933

B. Braun Medical Inc. began recalling the lots on March 21, 2008 as a precautionary measure. This product recall was initiated due to a notification received from the supplier, Scientific Protein Laboratories (SPL), disclosing that one lot of Heparin Sodium, USP Active Pharmaceutical Ingredient acquired by B. Braun Medical Inc. has a heparin-like contaminant. To date, B. Braun Medical Inc. has not received any adverse event reports related to this issue.

The Food and Drug Administration has received reports of serious injuries and/or deaths in patients who have been administered Heparin injectable products of other companies containing this contaminant. As indicated in the notification issued by the supplier SPL, typical symptoms include anaphylactic-like reactions such as low blood pressure, shortness of breath, nausea, vomiting, diarrhea and abdominal pain.

Adverse reactions or quality problems experienced in the U.S. with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Adverse reactions or quality problems experienced in Canada with use of this product may be reported to Health Canada.  For details on how to report these reactions please refer to the following website:

Customers who have product in their possession from the recalled product lots should discontinue use immediately.  Patients reporting any problems that may be related to the use of this product should be advised to contact a physician. Customers may contact B. Braun Medical Inc. Customer Support Department at (800) 227-2862 for U.S. and (800) 624-2920 for Canada, Monday through Friday, 8 AM to 7 PM EST for instructions for handling the affected product and to arrange for replacement product.

 

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