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Baxter International Inc. 7 articles

Bayer recalls bacteria filters used in compounding pharmacies

Baxter International Inc., is recalling all unexpired lots of 50mm 0.2 micron filters used to filter bacteria and particulate matter in compounded solutions, such as those manufactured by compounding pharmacies. The recall was initiated because of issues with a component of the filter made by an external supplier, and was identified as a result of complaints from compounding facilities. Without the filter support membrane, the bacteria and/or particulate matter present in an unsterile solution could pass through to the compounded prepared solution. If not filtered again before the product is administered to a patient, this defect could cause adverse health ... Read More

Device used during carotid endarterectomy surgery linked to serious bleeding, deaths

Baxter International Inc.’s Vascu-Guard Peripheral Vascular Patch (Vascu-Guard patch) used during carotid endarterectomy (CEA) surgery has caused several patients to suffer intraoperative or postoperative bleeding and hematomas, some of which required clinical intervention. Three patient deaths that occurred shortly after CEA surgery may also be related to this issue, the Food and Drug Administration (FDA) warned. “The FDA is concerned that the Vascu-Guard patch may not be performing as intended and that patients who are treated with the product may be at risk for serious adverse health consequences, such as severe bleeding, hematomas, and death. After CEA surgery in particular, ... Read More

Heparin producer's insurers file lawsuit

The insurance companies for Scientific Protein Laboratories’ parent company, American Capital Ltd., are suing to nullify the policies with the laboratory, according to The Daily Record. The Wisconsin-based company entered a joint venture with Baxter International Inc. to produce heparin in China. Last year, heparin produced at that plant was found to have been contaminated with oversulfated chondroitin sulfate (OSCS), a heparin-mimicking material that can cause life-threatening allergic reactions. The contaminated heparin killed more than 80 people in the U.S. and sickened hundreds more before several batches of the blood thinner were recalled. American Capital purchased 87 percent of Scientific ... Read More

Another lawsuit filed in tainted heparin scandal

Another lawsuit has been filed against the Wisconsin-based heparin manufacturer, Scientific Protein Laboratories and one of its major distributors, Baxter International Inc., claiming the companies allowed contaminated batches of heparin to reach hospitals and medical facilities, where it led to the death of a 59-year-old hemodialysis patient, according to The News-Enterprise. Franke Leon Isom of Webster, Ken., died Dec. 14, 2007, a day after he was given heparin during treatment at Woodland Dialysis Clinic in Elizabethtown. Attorneys argue that Isom received part of the 55,000 gallons of heparin that was contaminated with over-sulfated chondroitin sulfate (OSCS). Earlier this year, a ... Read More

FDA makes blunder during hiring of PR firm to improve image

Every company can use a good spin doctor from time to time, and it looks like the Food and Drug Administration (FDA) is no exception. Last month I told you that California Rep. Harry Waxman, who serves as head of the House Oversight and Government Reform Committee, raised concerns that items outlined on the FDA’s 2007 priorities list appeared to prioritize industry desires over consumer protection. This, just months after more than 80 American deaths were linked to tainted heparin that was made in Baxter International Inc.’s facility in China. FDA officials later acknowledged they had not inspected that facility ... Read More

Candidates review reimportation of prescription drugs

Recent scares of tainted medicines and goods from foreign countries, such as contaminated batches of heparin from China, have spurred presidential nominees Sen. Barak Obama and Sen. John McCain to review their support for individuals to import cheaper drugs from other countries, Reuters/Boston Globe reported today. According to the report, aides for both candidates said that recent health scares had dampened their candidates’ enthusiasm of reimportation. Neither candidate has abandoned the prospect; however, they admit it has become a more controversial subject. Other countries, such as Canada, have government price controls that keep prescription drug costs down, making reimportation of ... Read More

Baxter expands heparin recall

In February, Baxter International Inc. announced it would expand its recall of heparin sodium injection products. In January, 2008, the company recalled nine lots of a heparin product as a result of reports of adverse patient reactions. It suspended production of the products in early February. The new expanded recall includes all remaining lots and doses of Baxter’s heparin sodium injection multi-dose, single-dose vials and HEP-LOCK heparin flush products, both preserved and preservative-free. The recall will not include Baxter’s heparin pre-mix IV solutions in bags. Although there was a danger of contamination that could result in adverse patient reaction, the ... Read More