Heparin Recall

Baxter’s recall of its heparin is now wider than initially started, largely because the FDA feels that there is enough substitute heparin in the market place to replace the questionable heparin made by Baxter. Initially, the “FDA and Baxter concluded that removing additional lots and doses of Baxter’s heparin from the market earlier would have created more risk to patients requiring heparin therapy than the increased potential for experiencing an adverse reaction.”

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 product and suspended production earlier this month.
Heparin Recall - Baxter widens it’s initial recall.

The FDA has now concluded that there is sufficient capacity on the part of other suppliers that Baxter’s recall will not jeopardize access to this drug, and has told Baxter that the company can now proceed with recalling its remaining heparin sodium injection and heparin flush products.

Although the vast majority of the reports of adverse reactions have been associated with the multi- dose products, Baxter is taking the precautionary step of recalling all remaining heparin sodium injection and heparin flush products that are currently on the market. In addition to the previously recalled lots of heparin sodium injection 1000 units/mL 10mL and 30mL multi-dose vials, Baxter’s recall will now include 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.

Heparin recall lawsuit

The Food and Drug Administration (FDA) after investigating cases of people across the country that got sick after being administered Heparin intravenously came to an inescapable conclusion that these life saving drugs are filled with life threatening ingredients. Evidences: - many people getting sick and some even dying while being administered heparin, many during dialysis. This led drug manufacturer, Baxter to recall the product from the market.

The adverse reactions occur shortly after intravenous administration and could be fatal. The reason for this gruesome irregularity is even more painful-maximizing profit. The Chinese firm which supplies an active ingredient of heparin had been using contaminants to reduce costs and to the patient’s plight was able to hoodwink both the FDA and the Chinese drug agency. Such negligence on the part of manufacturers has caused great losses to the victims and their families and should be punished by the law. It’s victim’s right to legally fight the wrongdoer by filing a heparin recall lawsuit with the help of their attorney and thus get their due compensation from the manufacturer who should have recognized the contaminated heparin as sub potent during their quality tests which could have saved it’s users from dire consequences.

Thus Heparin recall lawsuits are being reviewed by heparin lawyers all over. People who have lost loved ones can receive some sense of justice with the heparin recall lawsuit. Your claim may include loss of job, funeral and burial bills, pain and sufferings, out of pocket expenses, permanent disability costs.

Contact a heparin lawyer if you have also gone through this. React timely as Heparin recall lawsuits are time bound and it is very important to have the knowledge about the heparin lawsuit so that no one can misguide you or deprive you of your claims.

Heparin Recall is a major recall because of the amount of uses it has and the amount of people who use it on a daily basis. Heparin, a blood thinner, manufactured by Baxter, is used in many different ways. It is used for patients that are suspected of having heart attacks to patients that are using dialysis.  There are over 450,000 people who use Heparin every day.

Heparin has been linked to several deaths and hundreds of life-threatening adverse reactions. The Baxter’s Heparin recall is the result of problems in the Chinese manufacturing heparin manufacturing process.

Adverse reactions have included: stomach pain or discomfort; nausea; vomiting; diarrhea; low blood pressure; chest pain; fast heart rate; dizziness; fainting; unresponsiveness; shortness of breath; tachycardia; 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.

 If you suspect that you or someone you know has been contaminated by Heparin in the death, sudden and severe onset of adverse reactions during dialysis between September  2007 and May 1, 2008, please fill out our request form or give us a call at 866-335-8999 and one of our Heparin Recall Lawyers will contact you as soon as possible.  (Please note that certain hospitals still had recalled lots in their pharmacies after May 1, 2008.)