The Food and Drug Administration (FDA) today issue a press release for Actavis Totowa LLC. The manufacturer located in Morristown, NJ has issued a Class 1 recall of all strengths of their digitalis tablets manufactured under the name Digitek. Distribution of the defective products is by Mylan Pharmaceuticals using their Bertek label, and by UDL Laboratories using their UDL label.

The digitalis tablets came out of manufacturing with a double thickness of the tablet, meaning each tablet is a double-dose of the medication. Since Digitek is taken to correct abnormal heart rates and for heart failure, the double-dose poses quite a risk as well digitalis toxicity which can cause renal failure. The symptoms of excess Digitek in the system can be nausea, vomiting, dizziness, low blood pressure, cardiac instablity and bradycardia (abnormally slow heart rate).

Patients taking either of these medications should contact Stericycle, a pharmaceutical recall service company, at 1-888-276-6166 and contact their medical providers immediately.

Labels: Defective products

It has been reported that 81 deaths in the U.S. can be linked to a contaminated supply of the drug heparin, a blood thinner, imported from China. The deaths were centered around dialysis patients who use the defective products on a regular basis.

The Food and Drug Administration (FDA) and Chinese officials are at odds as to where the contamination occurred. Although the Chinese agreed that the heparin was contaminated, they said the deaths could not be attributed to the contaminant and they want to inspect the factory where the heparin was put into vials.

U.S. government officials are considering increased funding which will add more FDA inspection offices in China and increased inspections of the drug before it is exported. FDA director Dr. Janet Woodcock,

"assured patients, however, that all heparin supplies in the United States had
been tested with the most sensitive assays and had been found to be
uncontaminated."

Labels: Defective products

Everyone knows that the cost of prescription medications in the U.S. is extremely high and its taking a bigger and bigger piece of the family income, particularly that of senior citizens.

According to the About.com:Senior Health, one in four Americans has no prescription drug insurance. This often forces them to buy their prescription drugs on the Internet through online "pharmacies". The U.S. Food and Drug Administration (FDA) understands this need to search out the best price for your medications, but they want to make certain that you are getting safe drugs from Internet.

They caution consumers that not all online pharmacies are licensed to sell drugs in the U.S. You can't even be certain there is a licensed pharmacist on staff to help you. Therefore, any information you get may not be accurate or you may get the wrong medication. There is also no guarantee that they will keep your personal information private.

The FDA also warns that some of the medications bought online may not be medicine at all; they may be bogus pills. You also cannot be certain the the strength of the medication matches your prescription or even if they are out of date so may not work at all. Since you don't know where these pharmacies get their medications, you are not guaranteed that they don't include hazardous ingredients or that they are produced within our quality control standards.

The FDA is not in the business of trying to stop you from getting the best price for your presciptions by buying online. They just want you to do so safely and to protect yourself from unscupulous pharmacies.

For more complete information, please see their Consumer Safety Guide that has some very simple rules to follow before you make your online purchases.

If you or one of your family members has been injured by fake, expired or unsafe medications from an Internet purchase, contact one of our experienced attorneys for a free consultation.

Labels: Pharmacy Errors

The US Food and Drug Administration (FDA) issued a notice of immediate recall of several defective dietary herbal supplements due to a risk of health problems.

Herbal Science International Inc. is recalling twelve of its supplements at the direction of the FDA due to the health hazard that they pose. Nine of the products being recalled contain the ingredient ephedra which has the botanical component ephedrine alkaloids. Ephedrine alkaloids are "adrenaline-like stimulants that can have potentially dangerous effects on the heart." They can cause blood pressure to go up and can have the same effects as a stroke or heart attack.

Two of the other products being recalled have the ingredient aristolochic acid. Arisitolica acid is a strong carcinogenic and nephrotoxic botanical chemical. Taking supplements containing these ingredients poses a risk for kidney failure.

The product containing human placenta is being recalled because the FDA has not approved human placenta for human consumption. It is illegal to sell it in the US as it can carry disease.

The products are being sold under the following labels:
Wu Yao Shun Qi San
Qing Bi Tang (Nasal Cleanser)
Zhong Fong Huo Luo Wan (Stroke Revito Formula)
Xiao Qing Long Tang (Little Green Dragon)
Ding Chuan Tang
Xiao Xu Ming Tang
Feng Shi Zhi Tong Wan (Joint Relief)
Guo Min Bi Yan Wan
Fang Feng Tong Sheng San

The FDA is asking consumers to discontinue using these defective products at once and return them to their retailer for a refund. If you have taken these products and have felt any adverse reactions, you should contact your physician immediately. If you have questions or are unsure of the products, you can call Herbal Science at 626-333-9998 or the FDA at 800-FDA-1088.

A 60 year-old female driver unexplainably lost control of her car causing a terrible auto accident on a busy highway in Lauderhill yesterday.

The Nissan ricocheted off another vehicle going the same direction and headed directly for a bus stop where it struck three victims. One of the female victims landed on the hood of the Nissan and was carried over 500 feet - all the while the car was mowing down a street sign, bouncing off vehicles and crashing through a hedge. The victim on the hood of the car at last ended up on the ground in the parking lot of a church and did not survive. Another victim taken to a local hospital was stuck by the flying One-Way street sign.

The driver was taken to the hospital with chest pains and it was not determined if the accident caused the pain or the pain caused the accident.

One local police officer likened the car crash scene to that of a billard table as the car bounced off the several cars.

Labels: Auto Accident

A two-car auto accident on I-95 last Saturday killed two victims and the one who hit them walked away with only minor injuries.

The two victims, a couple from New Jersey, were travelling either very slowly or almost stopped, according to Florida Highway Patrol, when a 23 year-old man from Boca Raton slammed into their slow moving vehicle. Both vehicles slid almost 100 yards, then burst into flames.

A sheriff deputy from Broward County tried to rescue the victims but the intense flames prevented him from doing so. Witnesses said the scene was horrifying as the flames leaped 20 - 30 feet in the air.

Labels: Auto Accident, Wrongful Death

According to the Orlando Sentinel, in an effort to reduce auto accidents, Florida may be the next state to make it illegal to text-message while driving. Sen. Carey Baker, R-Eustis, is sponsoring the bill which would allow officers to ticket drivers who were texting and driving if they were pulled over for some other traffic violation. There would be a $60 fine for the offense.

While there are many other distractions that effect driver safety such as cell phone use, mapping your route from a GPS system, or even eating, Sen. Baker said the legislators were "drawing the line at texting."

The ban on texting while driving will be attached to the legislation prohibiting minors from talking on their cell phones while driving.

Labels: Auto Accident

The National Traffic Highway Safety Administration has issued two recalls due to possible injury to a child in the event of an auto accident. Both cases involve the actual seat separating from the base unit, but one is if there is a car crash in the front and the other involves side impact auto accidents.

The first recall is for the Evenflo Discovery child seats manufactured by Evenflo Company, Inc. from 2005 through 2008. Approximately 1,000,000 Discovery model numbers 390, 391, 534, and 552 are being recalled because the seat may separate from the base in a "high impact side collision" providing no protection for the child. Consumers should contact Evenflo at 1-800-356-2229 or www.evenflo.con/discovery for instructions on getting an additional hook to ensure the seat remains stationary.

Combi USA Inc. is recalling approximately 67,000 Combi infant seats due to possible separation in a front end crash. The model numbers include 4400, 4515, 4520, 8065, 8074 8086, 8087 and 8520 and were made between October 2005 and December 2007. Consumers should contact Combi to obtain a repair kit at 1-800-543-7734 or www.combi-intl.com .