Following Morphine Recall and Other Generic Drug Problems, KV Pharma Suspends All Shipments

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KV Pharmaceutical, the parent company of generic drug maker Ethex Corp., has announced that they are suspending manufacturing and shipping of all products. The action is being taken following a series of manufacturing problems over the past year, which has led to several recalls of Morphine Sulphate and other generic drugs which were sold with more of the active drug than they were supposed to contain.

Although the suspension of shipping and manufacturing started on January 22, 2009, the action was not announced until yesterday.

The company also indicates that they anticipate most of their products which have already been distributed will be recalled, but the scope and depth of the recall is still being discussed with the FDA.

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KV Pharmaceutical (NYSE: KVa/KVb) manufactures and markets a variety of prescription drugs through its subsidiaries, Ethex Corporation for generic drugs and Ther-Rx Corporation for branded drugs.

Last year, at least five separate Ethex drug recalls were issued due to manufacturing problems which allowed oversized tablets to be commercially released, potentially containing up to twice the appropriate amount of the active pharmaceutical ingredient.

The recalls issued so far have involved Morphine Sulfate Extended Release, Morphine Sulfate Immediate Release, Dextroamphetamine Sulfate, Propafenone HCI, Isosorbide Mononitrate Extended Release and Hydromorphone HCI tablets.

A number of serious and fatal morphine overdoses have been reported among users who received oversized tablets sold by KV Pharma’s Ethex, and the company faces potentially substantial liability from users who are pursuing Morphine recall lawsuits.

Investors have also filed a class action lawsuit against KV Pharma alleging that the company issued false information about their compliance with FDA manufacturing and marketing regulations, and failed to disclose the disorder in their facilities that resulted in the sale of oversized tablets that could cause serious harm to users.

The decision to suspend all manufacturing and shipping activities also comes as KV Pharma is being investigated by the FDA and SEC.

Tags: Ethex, KV Pharmaceuticals, Morphine
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4 Comments

Scotty
I seek help filling a lawsuite against the DEA for interfearing with the Pharmacies being able to keep and supply me the Morphine and Delaudid that my qualified doctors have prescribed for me. My back bone and sholder are all broken up and I am in dire need of these meds to live life without torture. Someone please help me to proceed through the courts. I am miserable to the bone, and why? Can’t they stop the druggies without killing the rest of us.. I’m sure they can. Someone please help me to fight them…Thanks… Scotty
johann
why don’t we take some tax money (this time WELL spent) and a one time fee of 1 % of the annual profits (not revnues) from each drug manufacturer and create an “e-mail address chain”. the data is already in the DEA computers. Put every physician and every pharmacy on that list and when there is a recall, the FDA/DEA can write it, one push of the send button and -according to numbers I have looked up- we should have a total of about 300 K doctors and 100K pharmacies in the u.s., let’s say 500K addresses altogether. to string them together should take an even slow co. 2 weeks at most. then a recall is relayed to everyone within a few seconds (probably 24 hrs before everybody reads it ) and not weeks or months. With the 1 % contribution you could create dozens of such “strings” and since all doctors and pharmacies Have to be licensed, EVERYBODY would be informed. We are talking about patient’s life here, potent drugs, not some vitamins. So our new government can show how much they are on the ball. Plus, people should be not SO trusting. Just because a dr. gives you a Rx and the pharmacist fills it does not mean you should take it sight unseen. There are a lot of ways to doublecheck (2nd opinion, compare label and drug’s appearance etc..) Unfortunately, there are mostly elderly patients who are not as informed etc., so that’s where friends, familymembers etc. come in. Yes, patients should be able to trust the government and doctors and pharmacies, but they have ALL made mistakes in the past, no? Some selfprotection is also needed and if a patient is not quite sure, ASK ANOTHER DR. OR PHARMACIST!!. As for the FDA and DEA to create a “protection wall”: get cracking!!
john
all recalls should by law be published to at least all physicians and/or pharmacies or in a government paid ad in a major newspaper as soon as a recall occurs. we spend 100 billion for an AIG bailout but who really cares about the public’s health??
Christine
I have been taking this drug from Ethex and I was not notified regarding this recall. When I called my pharmacy they were not aware of the problem and told me to call back Monday? I was effected by this drug where I just wanted to sleep, not eating, and my respatrory system was very very shallow. I could not function on this mediacation now I know why,. I was trying to locate the drug and that is when I was informed there was a recall on this. I fell as though I should have been contacted ASAP and was not? I find this very distrught and I don’t know what to do. I felt that I was going to die when taking this. I dicussed with my Dr that I couldn’t keep my eyes open, and I felt awful. Then I find out through the FDA site this was on the recall list. I stopped using this medication as soon as I found out this major problem had occured

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