B. Braun Recalls Heparin Lots After Supplier Finds Contamination

 

March 24, 2008

March 24, 2008 - B. Braun Medical Inc. was recently notified that 23 lots of its blood-thinning products containing heparin sodium USP active pharmaceutical ingredient are being recalled as part of the nationwide safety recall of heparin, prompted after the FDA found contamination in raw heparin stock imported from China.

The FDA has received reports of serious injuries and 19 deaths in patients who were administered heparin injectable products of other companies containing the contaminant. The FDA said last week the contaminant is oversulfated condroitin sulfate, which is used as a dietary supplement for joints, but can mimic heparin's blood-thinning properties in its oversulfated state. The FDA said as much as 50 percent of the recalled heparin was made up of the cheaper, substitute drug.

B. Braun began recalling the lots on March 21 as a precautionary measure. The company said the product recall was initiated after being notified by the supplier, Scientific Protein Laboratories (SPL), that one lot of heparin sodium, USP active pharmaceutical ingredient acquired by B. Braun had the contaminant. To date, B. Braun said it has not received any adverse event reports related to this issue.

As indicated in the notification issued by the SPL, typical symptoms include anaphylactic-like reactions such as low blood pressure, shortness of breath, nausea, vomiting, diarrhea and abdominal pain.

The voluntary recall affects the following 23 finished product lots manufactured and distributed by B. Braun Medical Inc. nationwide and to Canada. The recalled lots below are listed by B. Braun FP lot number first, followed by B. Braun FP material, description, U.S. NDC numbers, and ending with Candian DIN numbers:

- J7D490, P5872, Heparin Sodium 25,000 Units in 5 percent Dextrose Injection (250mL), 0264-9587-20

- J7C684, P5771, Heparin Sodium 25,000 Units in 5 percent Dextrose Injection (500mL), 0264-9577-10

- J7D496, P5771, Heparin Sodium 25,000 Units in 5 percent Dextrose Injection (500mL), 0264-9577-10

- J7C470, P5872, Heparin Sodium 25,000 Units in 5 percent Dextrose Injection (250mL), 0264-9587-20

- J7D580, P5671-00, Heparin Sodium 20,000 Units in 5 percent Dextrose Injection (500mL), Canadian DIN 02209713

- J7E420, P5872-00, Heparin Sodium 25,000 Units in 5 percent Dextrose Injection (250mL), Canadian DIN 02209721

- J7C611, P8721 Heparin Sodium 1000 Units in 0.9 percent Sodium Chloride Injection (500mL), 0264-9872-10, Candian DIN 01935933

- J7C557, P8721, Heparin Sodium 1000 Units in 0.9 percent Sodium Chloride Injection (500mL), 0264-9872-10, 01935933

- J7C477, P8721, Heparin Sodium 1000 Units in 0.9 percent Sodium Chloride Injection (500mL), 0264-9872-10, 01935933

- J7C705, P8721, Heparin Sodium 1000 Units in 0.9 percent Sodium Chloride Injection (500mL), 0264-9872-10, 01935933

- J7D485, P8721, Heparin Sodium 1000 Units in 0.9 percent Sodium Chloride Injection (500mL), 0264-9872-10, 01935933

- J7E415, P8721, Heparin Sodium 1000 Units in 0.9 percent Sodium Chloride Injection (500mL), 0264-9872-10, 01935933

- J7E416, P8721, Heparin Sodium 1000 Units in 0.9 percent Sodium Chloride Injection (500mL), 0264-9872-10, 01935933

- J7E494, P5872, Heparin Sodium 25,000 Units in 5 percent Dextrose Injection (250mL), 0264-9587-20

- J7E500, P5771, Heparin Sodium 25,000 Units in 5 percent Dextrose Injection (500mL), 0264-9577-10

- J7E577, P5771-00, Heparin Sodium 25,000 Units in 5 percent Dextrose Injection (500mL), Canadian DIN 01935941

- J7E489, P8721, Heparin Sodium 1000 Units in 0.9 percent Sodium Chloride Injection (500mL), 0264-9872-10, 01935933

- J7N556, P5872, Heparin Sodium 25,000 Units in 5 percent Dextrose Injection (250mL), 0264-9587-20

- J7P404, P5771, Heparin Sodium 25,000 Units in 5 percent Dextrose Injection (500mL), 0264-9577-10

- J7N604, P5771, Heparin Sodium 25,000 Units in 5 percent Dextrose Injection (500mL), 0264-9577-10

- J7P476, P5872, Heparin Sodium 25,000 Units in 5 percent Dextrose Injection (250mL), 0264-9587-20

- J7N519, P8721, Heparin Sodium 1000 Units in 0.9 percent Sodium Chloride Injection (500mL), 0264-9872-10, 01935933

- J7N676, P8721, Heparin Sodium 1000 Units in 0.9 percent Sodium Chloride Injection (500mL), 264-9872-10, 01935933


Adverse reactions or quality problems experienced in the U.S. with the use of these products can be reported to the FDA's MedWatch Adverse Event Reporting program either online at www.fda.gov/medwatch/report.htm, or by fax at 1-800-FDA-0178.

Adverse reactions or quality problems experienced in Canada with use of this product may be reported to Health Canada at www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/index_e.html

B. Braun said 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 a.m. to 7 p.m. EST for instructions for handling the affected product and to arrange for replacement product.

For more information: www.fda.gov/medwAtch