DRUG ALERT : Ethex Corporation Recalls Overdosed Propafenone Tablets

As first reported on November 11th, there has been a Propafenone recall by the ETHEX Corporation because the pills may have been oversized, which could result in overdose of the drug Propafenone.

Three different strengths were recalled, all of them Propafenone HCI tablets made by the ETHEX Corporation. They were 150mg, 225mg and 300mg pills from any of the following lots with expiration dates ranging from 6/2009 to 3/2011.

Below are the recalled lot numbers:

150 mg – 73761, 78184, 79373, 81240, 81241, 81242, 83470, 84357, 90525, 90526
225 mg – 71720, 74831, 76014-15, 81243-45, 89731, 90527-29, 90657
300mg – 72834, 76016-18, 81246, 89092, 89732, 90530, 90532, and 91641-42

The 150 mg Propafenone Hydrochloride pills are white, scored round film coated tablets with “ETH” on one side and “331? with a bisect on the reverse. The 225 mg Propafenone Hydrochloride pills are white, scored round film coated tablets with “ETH” on one side and “332? with a bisect on the reverse. The 300 mg Propafenone Hydrochloride pills are white, scored round film coated tablets with “ETH” on one side and “333? with a bisect on the reverse. Life threatening consequences of overdosing on Propafenone Hydrochloride includes heart arrhythmias (irregular heartbeat) and dangerously low blood pressure.

If you or someone you know is prescribed Propafenone, please call your physician immediately.An overdose of this substance is very serious, and can cause severe harm.

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Drug Recall: Morphine Sulfate 60 Mg Extended Release Tablets

The FDA has issued a recall today for morphine sulfate tablets because a certain batch was found to contain double the dosage as found in a single pill.  The warning from the FDA is as follows:

ETHEX Corporation notified health care professionals of a voluntary recall of a single lot of morphine sulfate 60 mg extended release tablets (Lot No. 91762) due to a report of a tablet with twice the appropriate thickness. Oversized tablets may contain as much as two times the labeled level of active morphine sulfate. The lot was distributed by ETHEX Corporation under an “ETHEX” label between April 16th and April 27th of 2008. Opioids such as morphine have life-threatening consequences if overdosed. Consequences can include respiratory depression (difficulty or lack of breathing), and low blood pressure. Many patients for whom this product is prescribed are likely to be highly debilitated with reduced strength or energy as a result of illness, and may be less likely to determine that a tablet is overweight or oversized than an unimpaired individual. If consumers have any questions about the recall, they should call their physician, pharmacist, or other health care provider.

Read the MedWatch 2008 safety summary, including a link to the firm’s press release regarding this issue at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Morphine

This “double thickness” issue also prompted the massive Digitek recall earlier this year.  The heart drug was recalled after a wide range of disturbing side effects were noted in patients, including low blood pressure, reduced heart rate and death.

Obviously, double coated morphine has the potential to cause similar injuries in users.  If you have noticed any of the side effects listed above after taking morphine, it is extremely important that you file a report with the FDA.

Furthermore, if you have been seriously injured as a result of taking this defective product, you may have rights against the drug manufacturer. To speak with a defective product attorney, please call (856) 833-0600 in NJ or (215) 567-2380 in PA or fill out the free case evaluation form on the left side of the page.
You will be contacted immediately for a free case evaluation.

The Latest Heparin News: Hillary Speaks Out On Dangerous Chinese Imports

After learning that Heparin from China has been contaiminated with a cheap man made chemical substitute (which has now been linked to 62 deaths and a whole host of other illnesses) Presidential Candidate Hillary Clinton has issued the following press release on her website:

“When it comes to the threat of unsafe drugs from China, the Bush administration is sitting on its hands and rolling the dice with our safety. Heparin is the latest example. Americans have a right to know that their government is taking their health and safety seriously.

With news accounts of a potentially tainted Chinese supply of the blood-thinning drug, heparin, and a new FDA report that the drug has caused hundreds of adverse reactions and 62 deaths, there is an urgent need for the administration to take decisive steps to protect patients from unsafe imported drugs. If George Bush won”t start that process now, I will when I am president.

As I laid out in my import safety agenda, I will require that foreign drug makers produce a certification that they have met American safety standards as a condition of import into the United States, confirmed by independent testing and inspection. I will open permanent FDA oversight offices in at-risk countries like China so that episodes like this one are not repeated. I will require foreign drug makers to accept random, surprise inspections, rather than notifying them in advance – and giving them a chance to clean up their act — as we do now. And I will stiffen civil and criminal penalties for violators.

It is a basic obligation of government to protect its citizens. Americans can count on me as President to protect the food we eat, the toys our children play with and the drugs we take to make us healthy, not sick.”

Its about time someone in Washinton spoke up about the influx of dangerous chinese imports that are hurting American consumers. And while most of us can choose not to buy Chinese toys or Chinese dog food, hospitalized Americans do not have that same freedom. Patients with heart conditions and those on dialysis depend on Heparin to prevent life threatening blood clots. How patheitc is it that these poor people have to worry about getting sick from Heparin because drug manufacturers wanted to save a few bucks. That my friends is greed at its worst.

John R.Mininno, Esq. is a New Jersey and Pennsylvania trial lawyer representing clients in medical malpractice, defective products and other serious injury claims. He also writes about issues concerning patient safety. His offices are in Collingswood, NJ and Philadelphia, PA.
For further information visit our medical malpractice website