Ethex Hydromorphone Recall: Latest in Series of Drugs Sold With Oversized Tablets

Another major Ethex recall was issued on December 23, 2008, this time involving generic Hydromorphone HCI tablets which may be oversized, posing a potential risk of overdose and other serious injury.

This is the fifth recall issued this year by Ethex Corp. due to oversized tablets of generic drugs, leading their parent company, KV Pharmaceutical, to suspend shipments of all drug products they manufacture in tablet form.

The Ethex Hydromorphone recall applies to one lot of 2 mg tablets with Lot #90219, NDC#58177-0620-04 and an expiration date of 03/2010. The drug is labeled under the “Ethex” name and packaged in bottles with 100 round and blue tablets, containing a “2” on one side an “E” on the other side.

It is possible that there may be oversized Hydromorphone tablets in this lot, which contain more of the active pharmaceutical ingredient than is appropriate.

Hydromophone is a prescription drug used for pain management. Receiving higher than expected doses could increase the risk of serious and potentially life-threatening side effects, such as difficulty breathing, respiratory depression, low blood pressure or sedation.

So far this year, under five separate recalls, at least 13 different variations of generic drugs manufactured under the Ethex name have been recalled due to potential oversized tablets being commercially released.

On June 10, 2008, the recalls started with one lot of Ethex Sulfate 60mg Extended Release tablets. A few days later, Ethex expanded their Morphine recall to add 64 more lots of 30mg and 60mg Morphine Sulfate ER tablets.

Morphine is an opioid which can lead to a fatal overdose if too much of the medication is received, and a number of potential Morphine overdose lawsuits are currently being investigated against Ethex for allowing oversized tablets to leave their factory.

On October 15, 2008, Ethex issued a Dextroamphetamine Sulfate recall for three lots of their 5mg tablets. The following month, additional Dextroamphetamine Sulfate 10mg tablets were recalled along with additional Morphine and other generic drugs, including Propafenone HCI tablets and Isosorbide Mononitrate ER tablets.

KV Pharmaceutical, which is the parent company of Ethex Corp., advised the FDA on December 19, 2008 that they are suspending shipment of all FDA-approved drug products in tablet form. This will allow the drug maker to address manufacturing issues which have been plaguing the company all year, and improve their quality systems to prevent tablets with incorrect doses from being commercially released in the future.

As a result of the suspension of KV Pharmaceutical and Ethex tablet drugs, shipments will be discontinued for Benazepril HCl Tablets, Buspirone HCl Tablets, Dextroaphetamine Sulfate Tablets, Doxazosin Mesylate Tablets, Hydromorphone HCl Immediate Release Tablets, Isosorbide Mononitrate Extended-Release Tablets, Metoprolol Succinate Extended Release Tablets, Morphine Sulfate Extended Release Tablets, Ondansetron Orally Disintegrating Tablets, Oxycodone HCl Tablets, Potassium Chloride 20 mEq Extended-Release Tablets and Propafenone HCl Tablets.