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Audience: Pharmacists, consumers, primary care healthcare professionals
ETHEX and FDA notified heathcare professionals of a nationwide recall of a single lot of Hydromorphone HCl 2 mg Tablets due to potential for oversized tablets. Hydromorphone is a drug used for pain management. 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. The recalled tablets are a blue, round tablet with a script "E" on one side and a "2" on the other side.
The parent company of ETHEX Corporation, KV Pharmaceutical has advised FDA that it is voluntarily suspending shipments of all FDA-approved drug products in tablet form. This action is being taken as a precautionary measure, to allow KV to address manufacturing issues that have come to management’s attention.
Read the complete MedWatch 2008 Safety summary, including links to the Ethex and KV press releases and a list of KV products affected by the suspension, at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Hydromorphone
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
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