Baxter’s Heparin Issues Continue: FDA Admits Never Inspecting Chinese Manufacturer

Article: Baxter’s Heparin Issues Continue: FDA Admits Never Inspecting Chinese Manufacturer

Additional details about Baxter Healthcare Corporation’s, urgent recall of Heparin, a prescription injectable blood coagulant often used in hemodialysis (the filtering of blood) and cardiac invasive procedures, on January 25th 2008 are now being released. The Food and Drug Administration (FDA) has reported that it never inspected the Chinese manufacturing plant that provides Baxter with the active ingredient of the drug.

FDA admission

According to several news sources, the FDA, already under scrutiny for not adequately protecting the public against many harmful drugs and defective medical devices, admitted that it did not inspect the Chinese plant that provides Baxter with Heparin’s active ingredient – an enzyme taken from pig intestines – which has been linked to several adverse reactions to the drug.

The active ingredient is shipped to a Baxter facility in New Jersey where the final manufacturing process is completed. Baxter has reported that it inspected the plant outside of Shanghai, China less than months beforehand and that it plans to inspect it again based on this latest report.

Products affected by the recall

The recall affects the following products:

Heparin 1,000 Units/ML 10 and 30mL Multi-Dose Vials
NDC (National Drug Code) NUMBERS 0641-2440-45, 0641-2440-41, 0641-2450-45 and 0641-2450-41
LOTS: 107054, 117085, 047056, 097081, 107024, 107064, 107066, 107074, 107111

Symptoms associated with the drug

Baxter has advised that the following symptoms may be associated with the drug – some of which may be life threatening:

Discomfort, vomiting, diarrhea, decreased or low blood pressure, chest and stomach pain, fast heart rate, dizziness, fainting, unresponsiveness, nausea, 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.

If you’ve been injured due to Heparin use, contact an attorney to discuss your situation. The consultation is free and without obligation. To contact a qualified attorney whose practice focuses in this area of law, please click here.