Ethex has voluntarily recalled a single lot of morphine sulfate 60mg extended-release tablets due to a report of a tablet with double-thickness which may contain twice the level of active ingredient. There have been no reports of unexpected side effects or injuries, but the existence of double-strength tablets poses a risk of respiratory depression and low blood pressure. Patients prescribed this product are likely to be highly debilitated and less likely to determine that a tablet is oversized than an unimpaired individual.
Extended-release morphine sulfate tablets are indicated for prolonged relief of moderate-to-severe pain.
For more information call (800) 321-1705 or visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm092737.htm.