ETHEX Recalls Continue

Amanda Wick
Amanda Wick
Contributor
Posted by Amanda WickFebruary 12, 2009 10:24 AM

ETHEX CORPORATION and KV Pharmaceuticals Continuously Expand List of Recalled Drugs

If you've been watching the news or FDA recalls list lately, a name that pops up over and over again is ETHEX Corporation. Over the past several months, Ther-Rx Corporation and ETHEX Corporation, subsidiaries of KV Pharmaceutical Company, have issued urgent, nationwide recalls of several products due to their potential harm to consumers.

In November 2008, ETHEX Corporation issued a voluntarily recall of specific lots of at least four generic pharmaceutical products that it markets. These included:

  1. Morphine Sulfate Extended Release Tablets (15 and 30 mg)
  2. Dextroamphetamine Sulfate Tablets (10 mg)
  3. Propafenone HCl Tablets (150, 225, and 300 mg)
  4. Isosorbide Mononitrate Extended Release Tablets (30 and 60 mg)

According to the Food and Drug Administration, these lots were recalled due to the possibility that they may contain oversized tablets. These oversized tablets potentially contain more than the intended levels of the active drug ingredient, which can result in patients receiving nearly twice the prescribed dosage of the drugs. Overdoses of these drugs can have serious or life-threatening consequences which can include: irregular heartbeat, dangerous changes in blood pressure, fainting, difficulty or lack of breathing, and rapid heart rate.

A list of recalled drugs can be found by visiting the FDA website. Although the recall was originally issued at the wholesale level, it was expanded to the retail level in February 2009. This resulted in consumers receiving letters from their pharmacies that their drug had been recalled. However, by the time the pharmacy sent out the letter, patients had often already consumed the prescribed drugs and had thrown away the medication bottles. Please note that if you are taking a drug that is recalled, keeping your empty prescription bottles can be vital to the process of establishing causation between any injury you suffer and the recalled drug. Sadly, often the letters come out after a recall is issued and in some cases, after patients have taken the oversized drugs and have suffered illnesses or died.

The ETHEX recall debacle continued when, in January 2009, the ETHEX Corporation recalled an additional set of drugs because the products may have been manufactured under conditions that did not sufficiently comply with current FDA guidelines on Good Manufacturing Practices (GMPSs). The FDA guidelines on GMPs regulate various aspects of production including the design, manufacturing, packaging, labeling, storage, and installation of a product. These guidelines can be found on the FDA’s webpage. While some violations can be as small as improper packaging, other violations can cause the pills to be defective including coating that might be too thin, an active ingredient might be double in strength, and a number of other problems that could cause injury to consumers.

The ETHEX Corporation expanded its recall in February 2009 to include several prenatal and iron supplements. Recalls and letters issued to retailers and consumers, which contain instructions on how to return recalled products for a refund, can be viewed at the KV Pharmaceutical website.

If you or a loved one is currently taking or has an order in progress for any of the products listed above, contact your prescriber or health care professional immediately. While patients should continue to take medications in accordance with their prescriptions, as suddenly stopping needed medication may also place patients at risk, the best thing to do is to call your doctor immediately.

If you or someone you know was injured as a result of taking these medications, try to retain all documents, receipts and empty medication bottles related to the drug. This includes keeping any letters you may have received from your pharmacy regarding a recall. But especially, try to retain the prescription bottle in which you received the medication. And seek help from an attorney who will preserve your rights.

4 Comments

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concerned consumer
Posted by concerned consumer
February 13, 2009 6:43 PM

It is a shame this law firm has to scare people needlessly to gather client, by feeding into their fears erroneoulsy. Some of the people you are reaching out to have serious health conditions which require such medications in the first place. The FDA is aware which products are recalled at the wholesale level, and which are at the retail level, as one should be able to read themselves when they go to the FDA website you provide a link for. FDA did not require recalls this time at the consumer/patient level. The recent recalls are a result of FDA reviewing processes of GMPs before production and shipment resumes. This law firm did not do their homework and find out there is a third level of recalls to the consumer/patient level, which the FDA would require if they believed the products themselves to be at risk to consumers. It does appear on this instance your posting of misleading information to be the greatest risk to the consumer/patient.

Amanda Wick
Posted by Amanda Wick
February 19, 2009 2:31 PM

Dear Concerned Consumer,
Your comment that our firm "has to scare people needlessly to gather client [sic]" is insulting and your facts are false. On February 3, 2009, the FDA issued a report titled, "Previously Issued Recall to Wholesale Level On Certain Products Expanded to Retail Level." You may find the report at More ... Sadly, some of the people we are reaching out to DID have health problems before they overdosed on defective ETHEX pills and died. Sadly, some of the people who have reached back to us received their recall notices from their pharmacist several WEEKS after a loved one was injured or died of an overdose. This law firm DID do their homework, found the recall issued to the patient level, and felt strongly that pills that were made with double the active dosage were scary enough to post a warning about. I would strongly disagree with your argument that our posting that contained ACCURATE information was the greatest risk to the consumer/patient and would say that companies who make defective drugs that injure consumers are far scarier.

concerned consumer
Posted by concerned consumer
February 21, 2009 3:01 AM

Dear Amanda Wick,
You are still missing the point. There are three levels of recalls that can take place which are: wholesale level, retail level, consumer/patient level. If recall is only at the wholesale level, any retailer which has the product on their shelf can continue to dispense it. If the recall goes to the retail level, but does not include the consumer/patient level, the retailer has to return product and stop distribution into the marketplace. It is not required, I repeat... not required to contact the consumer/patient with warnings to stop their medication, return it, or exchange it. The FDA did not find any of the product(s) during these time periods to be defective or of concern for safety during the initial or expanded recall to the retail level. They merely are requiring all processes in manufacturing to be proven to be compliant before production and shipment can resume. Certainly, if a patient or loved one learned from a retailer that a company is under review by the FDA for processes in manufacturing that "assumed" they were to send out such notice, and feel that a risk to their life, or loss of life of a loved one, may have resulted from defective product(s), they should fully report or investigate this. All I was attempting to state was that the consumer/patient with an already compromised health can be induced to a heightened level of panic, which may further compromise their condition. If you truly are watching out for the best interest of the consumer/patient, please clearly define what the initial recall and the expanded recall really mean.

Amanda Wick
Posted by Amanda Wick
March 04, 2009 3:49 PM

I appreciate your clarification of what the recall levels mean in terms of notice required. However, if a recall at the retailer level requires that "the retailer has to return product and stop distribution into the marketplace," then whether that retailer directly contacts the patient or not, presumably the patient will find out there is a problem when they go to refill that prescription. In this situation, where some of the pills were found to have twice their regular dose and could lead to overdose, I guess I would have to respectfully disagree with the FDA if it "did not find any of the product(s) during these time periods to be defective or of concern for safety during the initial or expanded recall to the retail level." While I will try not to "induce a heightened level of panic" in the future, I certainly am not going to leave the health of my friends and family to an agency that is overworked, understaffed, and apparently thinks there's nothing wrong with a little double-dose here and there. While I appreciate the challenges faced by those who work at the FDA, I also think Consumers should be a little more aggressive at knowing what's going on and protecting themselves BEFORE they're injured, rather than waiting for the slow moving red-tape at the FDA to send you a recall notice after enough people are injured. Because it's then too little too late, despite their well-reasoned precautions to not "induce panic." I believe people should contact their health professionals if there is ever a question, but I would hesitate to rely on the FDA for "best practices" when it comes to your own health.

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