Baxter Healthcare Corporation has issued an immediate voluntary recall of nine lots of heparin sodium injection 1000 units/ml and 30 ml multi-dose vials.
The lots recalled are:
NDC NUMBERS 0641-2440-45, 0641-2440-41, 0641-2450-45 and 0641-2450-41
LOTS: 107054, 117085, 047056, 097081, 107024, 107064, 107066, 107074, 107111
"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, feeling your heart beat strong or fast, 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 and difficulty opening the mouth. Some of these reactions may be severe or life threatening."
Heparin is a prescription blood thinner (anticoagulant) used to prevent the formation of blood clots in acute coronary syndrome, atrial fibrillation, deep-vein thrombosis, pulmonary embolism and cardiopulmonary bypass.
Patients are instructed to discontinue use of the above lots of heparin and to contact Baxter for the return and replacement of the product.
Baxter: 1-800-667-0959
[Source: FDA]
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Tracked on: February 4, 2008 2:40 PM | Permalink to Trackback