BAXTER HEPARIN SODIUM MANUFACTURING RECALL
Heparin is a widely used anticoagulant that has many applications including keeping blood thin for dialysis procedures. Baxter International, one of the country’s largest suppliers of the drug has recalled nearly all of its various Heparin products. This recall came in the wake of reports of patients having severe adverse reactions to Heparin injections. 21 deaths have been identified as potentially linked to Heparin injections.
MANUFACTURING OVERSIGHT
All of the lots of the drug that have been reported to create complications in patients came from a pharmaceutical plant in China owned by Scientific Protein Laboratories of Waunakee, Wisconsin, one of Baxter’s primary suppliers. Many have been surprised by the revelation that there had been no evaluation of the manufacturing plant by either the FDA or any Chinese government agency. Only after the reports of negative reactions to the drug did the FDA sent a team of inspectors to the plant. Their investigation uncovered lax hygiene and safety standards. Additionally, the FDA noted testing procedures were inadequate and poorly documented. The greatest problem noted was the fact that it was impossible to trace the origin of the supply of raw materials, which in the case of Heparin come from the mucous linings of pigs’ intestines.
BAXTER'S RESPONSE
Officials within Baxter claimed to be surprised that there wasn’t any regulatory review of the manufacturing facilities in China, and said that it was not uncommon for them to have limited information about the facilities of their suppliers. They issued the recall "as a precautionary measure due to a higher than usual number of reports of adverse patient reactions involving the product" and have since suspended production of the drugs. The recall affects heparin sodium multi-dose and single dose vials, as well as HEP-LOCK heparin flush products.
CONTACT US
If you or a family member have received Baxter Heparin Sodium or any of the products subject to the recall and you would like to discuss your rights, please fill out the short evaluation form below and a member of Seeger Weiss LLP's experienced staff will contact you. Attorney consultations incur no obligation on your part and all initial consultations are free of charge and do not create an attorney-client relationship. Seeger Weiss LLP has office locations in New York, New Jersey, and Pennsylvania and its attorneys are available to practice in courts throughout the country.
Link To Lawyer Seek's Baxter Heparin Sodium Recall Content:
<a href='http://www.lawyerseek.com/Practice/In-The-News-C20/Baxter-Heparin-Sodium-Recall-P167/'>Baxter Heparin Sodium Recall: Lawyer Seek</a> |
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