Ethex Corporation has expanded their voluntary recall of morphine sulfate tablets to both 30 mg and 60 mg doses and additional lots of both doses. We reported a previous recall of a single lot of 60 mg tablets on June 11, 2008. There is a potential problem that some tablets may be oversized and may contain as much as twice the dose of morphine on the label.
No oversized tablets have been found in any of the additional lots now being recalled, but because the problem discovered in one lot, Ethex is taking extra precautions to ensure patient safety.
The 60 mg tablet is a white oval with “60″ on one side and “E” on the other. The 30 mg tablets are pink with “30″ on one side and “E” on the reverse.
Although there have been no reports of serious problems due to overdoses, the possibility exists for respiratory distress and very low blood pressure if too much morphine is taken.
Lots being recalled were distributed between June 2006 and May 2008. They include:
Morphine Sulfate ER 30mg Tablet/NDC # 58177-320-04: Lots 75090, 77846, 77847, 80048, 83320, 89661, 89665, 90252 through 90258, and 93284
Morphine Sulfate ER 60mg Tablet/NDC # 58177-330-04: Lots 91762 (previously reported), 75091, 75092, 77848 through 77851, 82517, 82518, 83333, 83817, 83862, 84111, 84112, 84315, 84900, 85326, 85335, 85807, 86270 through 86276, 87723, 87939, 88007, 89083, 89668, 89669, 89821, 90260 through 90272, and 91763 through 91765.
Patients or caregivers with questions about the recall should
- Contact their doctor or pharmacist
- Call ETHEX Customer Service at 1-800-321-1705
- Email firstname.lastname@example.org
Ethex representatives are available Monday through Friday, 8 am to 5 pm CST.
Patients who experience an adverse reaction to Ethex morphine sulfate extended release tablets or who have a quality problem with them should report them to the FDA MedWatch Program. Telephone1-800-FDA-1088,mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or use the MedWatch website at www.fda.gov/medwatch.