ETHEX Recalls One Lot Of Hydromorphone HCl (2mg) After Finding Oversized Tablet
At Same Time, KV Pharmaceutical Suspends Shipments of All ETHEX Tablet-Form Drugs For An Indefinite Period
(Posted by Tom Lamb at DrugInjuryWatch.com)
On December 23, 2008 KV Pharmaceutical announced another drug recall involving its subsidiary ETHEX Corporation. This latest recall involves "a single production lot of Hydromorphone HCl 2 mg tablets (Lot 90219, Exp: 3/2010; NDC 58177-0620-04), a pain management drug, following the report of an oversized tablet."
In the same December 23 press release, "KV Pharmaceutical Voluntarily Suspends All Shipments of Its Approved Tablet-Form Drugs", we learned that there is an effort underway to improve the "manufacturing and quality systems" as well as "to implement efficiency improvements" at the production facilities where ETHEX tablet-form drugs are manufactured:
KV Pharmaceutical (NYSE: KV-A) has advised the U.S. Food and Drug Administration (FDA) that, effective midnight Dec. 19, 2008, the company voluntarily suspended all shipments of all FDA approved drug products in tablet form. This action is being taken as a precautionary measure to allow KV to expeditiously review and enhance comprehensively the company's manufacturing and quality systems, and to implement efficiency improvements in its production facilities. KV is keeping the FDA informed about the company's plans.
The list of ETHEX drugs covered by this December 2008 suspension of shipments follows:
- Benazepril HCl Tablets
- Buspirone HCl Tablets
- Dextroaphetamine Sulfate Tablets CII
- Doxazosin Mesylate Tablets
- Hydromorphone HCl Immediate Release Tablets, CII
- Isosorbide Mononitrate Extended-Release Tablets
- Metoprolol Succinate Extended Release Tablets, USP
- Morphine Sulfate Extended Release Tablets, CII'
- Ondansetron Orally Disintegrating Tablets
- Oxycodone HCl Tablets, CII
- Potassium Chloride 20 mEq Extended-Release Tablets
- Propafenone HCl Tablets
As we have reported previously, there have been several earlier recalls of ETHEX drugs in 2008:
Another "Double-Dose" Pill Problem Demonstrates How And Why The Digitek Recall Is So Unusual
A New "Double-Dose" Pill Drug Recall Is Issued By ETHEX Corp.
We will watch for further news from KV Pharmaceutical about the new single-lot recall of Hydromorphone HCl 2 mg tablets as well as the shipment suspension of all ETHEX tablet-form drugs.
P.S. Sometime after the above article was posted yesterday, this press release, "ETHEX Corporation Initiated Nationwide Voluntary Recall of a Single Lot of Hydromorphone HCl 2 mg Tablets Due to Potential for Oversized Tablet", was published on the FDA web site.
From the December 23 ETHEX press release we get some additional information from this generic drug company about its December 2008 recall of a single lot of Hydromorphone tablets:
If someone were to take a higher than expected dose of Hydromorphone, the risk of adverse effects known to be associated with the drug may be increased, including respiratory depression (difficulty or lack of breathing), low blood pressure, and sedation.
There are other companies in the United States producing and marketing versions of Hydromorphone HCl tablets and consumers and their caregivers are encouraged to check their prescriptions to determine the source of their tablets. Hydromorphone HCl 2 mg tablets marketed by ETHEX are a blue, round tablet with a script "E" on one side and a "2" on the other side.
Now we will wait to see if this Hydromorphone recall is expanded beyond the single lot identified initially by ETHEX.
