On December 19, 2008, KV Pharmaceutical advised the U.S. Food and Drug Administration (FDA), that the company has voluntarily suspended all shipments of drug products in tablet form.
Also included in the recall is a single production lot of Hydromorphone HCI 2 mg tablets (Exp date: 3/2010, Lot 90219; NDC 58177-0620-04), a pain management medication packaged under the ETHEX label in 100-count bottles, following reports of oversized 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.
The company has provided additional details on their Web site, which can be viewed here.
The company is unable to pinpoint when distribution of tablet-form products will resume.
A full list of suspended products can be viewed on the Web site under “Tablets Effected by Shipment Suspension.”