Source: DGNews  |  Posted 3 years ago

ROCKVILLE, Md -- June 10, 2008 -- ETHEX Corporation announced today that it has voluntarily recalled a single lot of morphine sulfate 60-mg extended release tablets (Lot No. 91762) due to a report of a tablet with twice the appropriate thickness. Oversized tablets may contain as much as 2 times the labeled level of active morphine sulfate. The product is a white oval tablet with "60" on one side, and "E" on the reverse. Morphine sulfate is indicated for the relief of moderate to severe pain. It is intended for use in patients who require repeated dosing with potent opioid analgesics over periods of more than a few days.

The lot was distributed by ETHEX Corporation under an "ETHEX" label between April 16th and April 27th of 2008. No other dosage strength or any other lot of the 60-mg strength is affected by this recall.

SOURCE: US Food and Drug Administration