ETHEX Recalls Continue
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:
- Morphine Sulfate Extended Release Tablets (15 and 30 mg)
- Dextroamphetamine Sulfate Tablets (10 mg)
- Propafenone HCl Tablets (150, 225, and 300 mg)
- 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.