Morphine Sulphate 60 mg and 30 mg Extended Release Tablets Recalled

June 13, 2008—ETHEX Corporation of St. Louis, Missouri has expanded its earlier (June 9, 2008) voluntary recall of one lot of 60 mg Morphine Sulfate tablets to include additional specific lots of 30 mg and 60 mg Morphine Sulfate Extended Release tablets due to the potential that oversized tablets containing twice the appropriate dose may have been manufactured and commercially released.

The expanded recall follows a report that a tablet with double the appropriate thickness had been identified in a previously recalled lot of 60 mg tablets. Oversized tablets may contain as much as two times the labeled level of active morphine sulfate.

The following lot numbers are involved in the recall:

Morphine Sulfate ER 30 mg Tablet/NDC #58177-320-04:

Lots 75090, 77846, 77847, 80048, 83320, 89661, 89665, 90252 through 90258, and 93284

Morphine Sulfate ER 60 mg 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.

The recalled lots were distributed under an “ETHEX” label between June 2006 and May 2008. The 60 mg product is a white oval tablet with “60” on one side, and “E” on the other side. The 30 mg product is a pink oval tablet with “30” on one side and “E” on the reverse.

Side Effects Associated with Double-Strength Morphine Sulfate Tablets

Morphine Sulfate is a prescription drug that is used primarily in pain management for the treatment of moderate to severe pain. Opioids such as morphine can have life-threatening consequences if overdosed.

Side effects linked to ingestion of oversized or double-strength tablets include:

• Respiratory Depression (difficulty or lack of breathing)
• Low blood pressure
• Death

According to the FDA, many patients for whom this product is prescribed are likely to be highly debilitated with reduced strength or energy as a result of illness, and may be less likely to determine that a tablet is overweight or oversized than an unimpaired individual.

Consumers are advised to contact their health care providers if they have any medical questions regarding the recalled Morphine Sulfate tablets. Do not discontinue any medication without first consulting your doctor.