Ethex Corporation notified healthcare professionals of a voluntary recall of 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 two times the labeled level of active morphine sulfate. The lot was distributed by Ethex Corporation under an ‘Ethex” label between April 16th and April 27th of 2008.
An over dosage or over strength of opioids such as morphine have life-threatening consequences, including respiratory depression (difficulty or lack of breathing) and low blood pressure. Due to their illness, many patients for whom this product is prescribed are more likely to be highly debilitated with reduced strength or energy. Their impairment may make it more difficult to determine that a tablet is oversized than an unimpaired individual. For questions about the recall, consumers are encouraged to call their physician, pharmacist or other healthcare provider.
For any questions related to this action, please contact Ethex Customer Service (representatives are available Monday through Friday, 8 am to 5 pm CST):
Fax 1- 314-646-3751
For more information see http://www.fda.gov/oc/po/firmrecalls/ethex06_08.html.