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January 2008
Company:
Baxter International
Product:
heparin sodium injection multi-dose, single-dose vials and HEP-LOCK heparin flush products
DEERFIELD, Ill., Baxter International Inc. voluntarily recalled all lots and doses of its heparin sodium injection multi-dose, single-dose vials and HEP-LOCK heparin flush products. The company initially recalled nine lots of heparin sodium injection multi-dose vials on January 17, 2008 as a precautionary measure due to a higher than usual number of reports of adverse patient reactions involving the produc t. In addition to the previously recalled lots of heparin sodium injection 1000 units/mL 10mL and 30mL multi-dose vials, Baxter's recall included the remaining lots of those products and heparin sodium injection 5000 units/mL 10mL multi-dose vials, heparin sodium injection 10,000 units/mL 4mL multi-dose vials, heparin sodium injection 1000 USP units/mL, 5000 USP units/mL, and 10,000 USP units/mL single-dose vials, and all HEP-LOCK and HEP-LOCK U/P, 10 USP units/mL and 100 USP units/mL vials, both preserved and preservative-free. Nearly all reported adverse reactions have occurred in three specific areas of product use renal dialysis, invasive cardiovascular procedures and apheresis procedures. Reported adverse patient reactions have included: stomach pain or discomfort, nausea, vomiting, diarrhea, decreased or low blood pressure, chest pain, fast heart rate, dizziness, fainting, unresponsiveness, shortness of breath, the feeling of a strong or rapid heartbeat, drug ineffectiveness, burning sensation, redness or paleness of skin, abnormal sensation of the skin, mouth or lips, flushing, increased sweating, decreased skin sensitivity, headache, feeling unwell, restlessness, watery eyes, throat swelling, thirst, bleeding tendencies and difficulty opening the mouth. Some of these reactions, particularly profound and refractory hypotension, may be severe or life-threatening.
 
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