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Baxter Heparin Sodium Recall Facts:


Marketed By:

Baxter

Affected Drugs:

0641-2440-41
0641-2440-45
0641-2450-41
0641-2450-45

Recalled Lots:

047056
097081
107024
107054
107064
107066
107074
107111
117085

Regions of Practice:

New York
New Jersey
Pennsylvania
Nationwide
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Baxter Heparin Sodium Recall

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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 Heparin products. This recall came in the wake of reports of severe adverse reactions in patients who received Heparin injections. Twenty-one deaths have been identified as potentially linked to Heparin injections.

Manufacturing Oversight


All of the drugs that have been reported to create complications have been linked to lots that were manufactured in a pharmaceutical plant in China owned by Scientific Protein Laboratories, one of Baxter?s primary suppliers. Only after the reports of negative reactions to the drug did the FDA send a team of inspectors to the plant. Their investigation uncovered lax hygiene and safety standards. Additionally, the FDA noted that testing procedures were inadequate and poorly documented. The largest problem found was an inability to trace the origin of the raw materials, which in the case of Heparin come from the mucous linings of pigs? intestines.

Contact us regarding Baxter Heparin Sodium Recall; attorney consultations are free.

Baxter's Response


Officials within Baxter claimed to be surprised that the manufacturing facilities in China were not subject to regulatory review, 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, and affected the following lots: 107054, 117085, 047056, 097081, 107024, 107064, 107066, 107074, 107111.

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.

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