Archive for the 'Recall' Category

Beware of milk imported from China

Wednesday, November 26th, 2008

In the past month, the FDA has issued an import alert detaining ALL milk products, milk derived ingredients and finished food products containing milk from China due to the presence of melamine.

These foods include both human foods (bakery products, cereals, cheese, ice cream, soft drinks, and candy) as well as several types of pet foods (pet cat foods, pet dog foods, pet fish foods, other pet foods, laboratory animal feeds, pet and laboratory animal foods, byproducts for animals, dairy byproducts for animals, and animal waste feed products) imported from China.

According to the FDA, the melamine milk contamination started in infant formula but “these contaminated milk components appear to have been dispersed throughout the Chinese food supply chain…Reports of contamination have come from more than thirteen countries in Asia, Europe, and Australia, in addition to the United States.”

Time magazine has reported that the Chinese government continues to downgrade the severity of the problem. Some believe that the contaminated foods are “one of the most important factors resulting in the soaring number of birth defects in China.”

VIBE manufacturers told to recall machine

Thursday, November 6th, 2008

The people who manufacture a machine touted as a way to increase “inner-connectively to your DNA,” has been ordered to recall the device because it doesn’t do anything it claims to.

The Food & Drug Administration (FDA) has issued a Class I recall for the Vibrational Integrated Bio-photonic Energizer (VIBE) Machine Multi-Frequency Electromagnetic Field Generator sold by VIBE Technologies of Colorado.

The FDA says that that the VIBE Machine is not approved, and that the company’s claims that it can be used to treat or cure medical conditions and diseases such as cancer, depression, infection, and pain are unproven.

The company had further claimed that the machine “is a technological breakthrough that enhances the human body by helping it reach its optimum vibrational energy level.”

According to the FDA, it does no such thing.

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death.

Families sue hospital, drug maker over baby deaths

Monday, September 15th, 2008

According to an Associated Press story, the families of two newborns who died after they were inadvertently given massive doses of heparin have sued an Indianapolis hospital and the Illinois-based company that makes the blood thinner.

The suit filed recently in Marion Superior Court against Methodist Hospital and Deerfield, Ill.-based Baxter Healthcare Corp. doesn’t specify damages.

The suit was filed by an defective drug attorney for the parents of two of the three newborns who died in September 2006 following injections of heparin 1,000 times greater than the recommended dose for infants. Also suing are the parents of two infants who were overdosed but survived.

The error occurred in part because of a mix up over labeling.

A Baxter spokeswoman said the deaths were tragic but preventable, and it is vital that clinicians always read the name and dose of a drug before giving it to a patient. Baxter changed the labeling on its heparin vials in October 2007.

A spokesman for Clarian Health Partners, of which Methodist is part, said the company did not have all the details of the litigation and had no comment.

Actor Dennis Quaid and his wife sued Baxter last year after their newborn twins got massive doses of the blood thinner at a hospital.

These families aren’t the only ones battling drug companies over wrongful deaths due to defective drugs or defective labeling. It is advisable to locate an experienced defective drug attorney in case legal advice is necessary for a heparin lawsuit or settlement .

FDA strengthens arthritis drug warnings

Monday, September 8th, 2008

The US Food and Drug Administration (FDA) has ruled to include stronger warnings for fungal infections caused by arthritis drugs.

The warnings apply to drugs like Amgen, Inc.’s Enbrel, Johnson & Johnson’s Remicade, Abbott Laboratories’ Humira, and UCB SA’s Cimza. The drugs Enbrel, Remicade, and Humira were among the top 25 selling drugs last year, with $13.5 billion in combined sales.

They are usually used to treat rheumatoid arthritis. According to the FDA, at least 241 patients have developed histoplasmosis—an infection caused by a fungus found in the Ohio and Mississippi river valleys. Twelve of the 45 reported deaths were caused by doctors who didn’t recognize the infection and delayed treatment for the infection; even more deaths have been reported from other fungal infections.

The FDA has forced companies to strengthen their existing cautions in the strictest form of caution: a black box in the drugs’ prescribing information. The drug manufacturers must also educate doctors about the risks and symptoms of fungal infections.

Contaminated Heparin may lead to hospital fines

Monday, September 8th, 2008

The California Pharmacy Board is working towards citing and fining 94 California hospitals and their corresponding head pharmacists for not complying with a recall of the contaminated blood thinner Heparin.

In February, drug manufacturer Baxter Healthcare ordered a full recall of Heparin after concerns that the medication was contaminated. They stated that the drug was to be removed from circulation and not administered to patients.

However, in at least 29 of the California cases investigated, hospital pharmacies were thought to still be using the tainted Heparin. While the amounts of the fines are yet to be determined, the hospitals may face fines from both the California Pharmacy Board and the Department of Public Health.

Contaminated heparin is suspected in nearly 100 deaths and many hundreds of injuries over the last year. Several patients have file heparin lawsuits in order to begin recovering damages.

Another Fentanyl Pain Patch Recall

Wednesday, August 20th, 2008

Watson Pharmaceutical is recalling more of their fentanyl pain patches because of their tendency to leak harmful fentanyl gel.

The manufacturer is recalling the 75mcg/hr fentanyl transdermal system patches sold in the US from wholesalers and pharmacies. These defective drug patches are used to manage persistent chronic pain that requires constant treatment with opioids.

The recalled patches in particular are from lot number 92461850 and have an expiration date of August 31, 2009. These patches were shipped to customers between January 30, 2008 and March 19, 2008.

According to Watson, some of the patches in this lot have been leaking fentanyl gel and exposing it to patients or caregivers. Fentanyl gel is a highly addictive opiate that is 80 times more potent than morphine. Direct exposure can cause serious effects such as trouble breathing, extreme tiredness, confusion, or death.

Contaminated heparin tied to deaths

Monday, August 4th, 2008

According to a July 30 story published in the Chicago Tribune, the U.S. Food and Drug Administration, for the first time, has conclusively linked deaths of patients to specific lots of contaminated heparin made by Baxter International Inc.

In an interview, the FDA said it completed its review of 93 death reports related to heparin that the agency received from Jan. 1 to March 31, a period when there was a dramatic spike in potentially deadly allergic reactions from patients who had been injected with heparin. The popular blood thinner is used widely in large dosages, often before patients have dialysis or heart surgery.

Of 10 reports of death from severe shock known as anaphylaxis or hypotension, three of those could be traced to lot numbers of Baxter products that tested positive for an animal-like substance known as oversulfated chondroitin sulfate. Heparin lot numbers were not known for the other seven deaths from anaphylaxis or hypotension, so the FDA could not determine whether those seven patients received heparin contaminated with the substance.

“We have what looks like a cause and effect in some patients,” Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said in an interview, referring to the three deaths linked to contaminated heparin. “We know that they got contaminated heparin, and they died subsequently. This is one of the final links in the chain.”

Baxter recalled its heparin products in February in the wake of the spike in the number of the allergic reactions. In recent months, federal health officials and Baxter believe the oversulfated chondroitin sulfate was intentionally put into the product from suppliers in China

Several wrongful death lawsuits have already been filed against Baxter and other manufacturers who allowed contaminated heparin onto the market.

Digitek Dangers

Friday, August 1st, 2008

On April 25, 2008 Digitek (digoxin), a medication used to treat congestive heart failure, abnormal heart rhythms, and other conditions, was recalled due to the possibility that tablets were doubled in thickness and could contain twice the approved level of the active ingredient. The existence of double-strength pills pose a risk of digitalis toxicity, which can result in nausea, vomiting, low blood pressure, cardiac instability, bradycardia and even death.

 

If you or a loved one has been harmed by Digitek, or any other dangerous drug or product, contact the Digitek attorneys at Cappolino Dodd Krebs LLP today, at 1-800-460-0606 for a free evaluation of your legal rights.

Canadian Morphine Tablets Recalled

Saturday, July 12th, 2008

Canadian drug makers, Health Canada, are recalling ratio-Morphine SR 15 milligram, 30 milligram and 60 milligram tablets. The tablets are being recalled due to possible overdose risks.

The recall was initiated after complaints were received by KV Pharmaceutical, a U.S. drug manufacturer.

Some morphine tablets may be oversized, containing more prescription medication than indicated on the label. This could lead to potential overdose.

According to defective drug attorneys, the symptoms of a morphine overdose are:

• Abnormal breathing
• Abnormally low blood pressure
• Abnormally low heart rate
• Dizziness

If untreated, a serious morphine overdose may also result in a cardiac arrest or fatality. If a drug overdose is suspected, defective drug lawyers agree that it is important to contact a qualified medical professional.

FDA Announces Recall of Supplements

Friday, July 4th, 2008

This week, the U.S. Food and Drug Administration (FDA) announced the nationwide recall of two sexual supplements due to the presence of undeclared ingredients. Both supplements were distributed by Jack Distribution LLC, which voluntarily recalled the products.

The lots affected by the recall include “Rize 2 The Occasion” lot numbers CG-84, GD-98, CC-06 and CG-79 and “Rose 4 Her” lot number CG-78.

The FDA stated that the unauthorized drug found in the supplements has a similar structure to a common erectile dysfunction medication, which is known to cause serious adverse reactions. The drug found in the recalled products is called thiomethisosildenafil. It could cause a disruption in nitrates, which can significantly lower blood pressure and causing life-threatening adverse effects.

Defective drug attorneys are working to help those who have become seriously ill due to faulty medications.