SPL Recall of Heparin API Prompts B. Braun to Voluntarily Recall Finished Product

PharmaManufacturing.com
03/25/2008

Irvine, Calif.-based 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: J7D490, J7C684, J7D496, J7C470, J7D580, J7E420, J7C611, J7C557, J7C477, J7C705, J7D485, J7E415, J7E416, J7E494, J7E500, J7E577, J7E489, J7N556, J7P404, J7N604, J7P476, J7N519 and J7N676.

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.

• Online: http://www.fda.gov/medwatch/report.htm
• Regular Mail: use postage-paid FDA form 3500 available at:         http://www.fda.gov/MedWatch/getforms.htm.
• Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
• Fax: 1-800-FDA-0178

   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:

• Online: http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/index_e.html

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.