Consumer Alert: ETHEX and KV Pharmaceutical Recall
February 19, 2009
Copyright 2009. All rights reserved. On January 26, 2009, KV Pharmaceutical announced the voluntary recall of most of its products, in addition to the voluntary suspension of nearly all of its manufacture and shipping processes. According to KV Pharmaceutical, "[t]he scope and depth of the recall are currently under discussion with the U.S. Food and Drug Administration (FDA)."[1]
According to a press release posted by the FDA, the nationwide voluntary recall was initiated "as a precautionary measure because [the products] may have been manufactured under conditions that did not sufficiently comply with current Good Manufacturing Practices (cGMPs). Some of these products have had specific lots recalled earlier due to defects found, including oversized tablets delivering higher than labeled doses."[2]
The company advises that "[p]atients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these products, or to obtain replacement medications or prescriptions."[3]
ETHEX corporation, a KV subsidiary, issued a nationwide recall of a single production lot of Hydromorphone HCl 2 mg tablets in December 2008.[4] Hydromorphone is used for pain management. The recall was initiated "as a precaution, due to the possibility [the production lot] may contain oversized tablets."[5] According to the ETHEX, "[i]f 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."[6]
The January 2009 recall includes Benazepril, Dextrophetamine, Doxazosin, Isosorbide, Metoprolol, Morphine Sulfate, Oxycodone, Potassium Chloride, Propafenone, and Hydromorphone HCl, among others. For a full list of recalled products, please visit http://www.fda.gov/oc/po/firmrecalls/ethex01_09.html.
A medication overdose can be dangerous or even fatal. Attorneys at Robins, Kaplan, Miller & Ciresi L.L.P. are currently investigating claims on behalf of patients injured by KV Pharmaceutical products. If you wish to speak to a lawyer about a potential claim or injury caused by one of the recalled products, please call Dan O'Fallon at 612-349-8717 or Amy Hanf at 612-349-0917. You can also reach us toll-free at 1-800-553-9910 or send us an email at contact us.
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