Ethex Morphine Tablet Recall ExpandedJun 16, 2008 | Parker Waichman LLP
A recall of potentially over-sized morphine tablets has been expanded by Ethex Corp. The recalled morphine tablets could contain as much as twice the amount of active ingredient than is safe, putting users at risk of morphine overdose.
Ethex first recalled a single lot of morphine sulfate 60 mg extended release tablets (Lot No. 91762) last Monday. The recall was issued after Ethex received a report of one oversized morphine tablet in the affected lot.
Now, the Ethex morphine recall has been expanded to include several lots of 60 mg and 30 mg extended release tablets. According to the Food & Drug Administration (FDA) the recalled lots 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.
The 60 mg product is a white oval tablet with “60” on one side, and “E” on the reverse. The 30 mg product is a pink oval tablet with “30” on one side, and “E” on the reverse.
Ethex is characterizing the additional morphine tablet recall as a precaution, and says that no additional oversized tablets have been identified in the affected lots. No report of unexpected side effects or injury has been received. However, opioids such as morphine, have life-threatening consequences if overdosed. Those consequences can include respiratory depression (difficulty or lack of breathing), and low blood pressure, apnea, and hypotension.
This is the second time in less than two months that a prescription tablet has been recalled because it contained twice the active ingredient than what was listed on the label. In April, Actavis Towtowa recalled Digitek tablets because some of the medication was manufactured at twice the normal strength. According to the FDA, the Digitek defect could cause serious and even fatal reactions in user, and the agency deemed the action a Class I recall. According to the agency, there have been several reports of illnesses and injuries in patient taking Digitek. Actavis said it had 11 such reports.