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Recalled heparin still appearing in hospitals, pharmacies

Just because a drug has been recalled doesn’t mean that it has been eliminated from pharmacy and hospital inventory. According to the Associated Press/San Jose (California) Mercury Sun, during an investigation by the California Board of Pharmacy, heparin, which was recalled last winter, was found 94 times in California hospitals and at least 16 hospitals administered the drug to patients. Nearly 100 pharmacists and the hospitals they work for were fined $2,000 to $5,000 by the Board of Pharmacy, according to the report. The Food and Drug Administration (FDA) recalled heparin early last year after a large number of patients ... 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

China-made products cause safety concern

Heparin isn’t the only China-made product that has turned up contaminated and, in many cases, harmed others. Last March, a contaminant was found in batches of Heparin, supplied to Baxter International by its Chinese plant. The over-sulfated chondrotin sulfate in the heparin is blamed for causing more than 80 deaths and breathing problems in another 700 in the United States. In recent weeks, according to a Reuters/The Epoch Times, three children and more than 6,000 infants have become ill after consuming infant formula contaminated with toxic melamine, according to Reuters/The Epoch Times. Let’s recap some of the other made-in-China scares ... 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

APP ok to make heparin in Puerto Rico

This week APP Pharmaceuticals, headquartered in Schaumberg, Ill., announced it has gotten FDA approval to manufacture heparin at its Barceloneta, Puerto Rico, facility. The facility will manufacture three product codes of heparin sodium injection, USP. According to a report in the Pharmaceutical Business Review, APP currently manufactures nine products at its Puerto Rico facility, including doxycycline, azithromycin and diphenhydramine. The report says the company plans to manufacture more than 19 million units in Puerto Rico during 2008 and to eventually transfer more than 25 additional product codes to the facility. The recall of contaminated heparin manufactured in China has affected ... Read More

synthetic heparin in development

Robert Linhardt, a scientist at Troy, New York-based Rensselaer Polytechnic Institute, is leading a team of researchers who have developed a fully synthetic version of the blood thinner heparin. While the group has only produced a few milligrams of the substance, it is the first step in eliminating the risk of contamination currently associated with the drug, which is manufactured primarily from pig intestines. Linhardt was among the researchers who discovered the source of tainted heparin that was responsible for at least 149 deaths since the beginning of 2007. Manufacturer Baxter International, which supplies about half of the heparin used ... Read More

Deadly crash spurs tire valve recall

A deadly rollover auto crash in Florida prompted a federal investigation and recall of 6 million tire valve stems after investigators alleged the accident was caused by a cracked stem, according to a report published in Lawyers USA. The recalled product was manufactured in China by Shanghai Baolong Automotive Corp. between July 2006 and November 2006. There could be as many as 36 million of the potentially defective stems currently in use on a variety of automobiles. The investigation revealing the valve stem defects resulted from a lawsuit filed by the widow of Robert Monk, of Orlando, Fla., who was ... Read More

FEMA Trailers Toxic

On May 25, MSNBC reported that investigation continues in cases of illness resulting from FEMA trailers provided to evacuees from 2005’s Hurricane Katrina. Formaldehyde was detected in the travel trailers and mobile homes in unusually high levels, and about 17,000 people are claiming the homes caused illnesses for themselves or loved ones. This report was written by MSNBC’s Spencer S. Hsu. WASHINGTON – Within days of Hurricane Katrina’s landfall in August 2005, frantic officials at the Federal Emergency Management Agency ordered nearly $2.7 billion worth of trailers and mobile homes to house the storm’s victims, many of them using a ... Read More