The FDA has issued a recall today for morphine sulfate tablets because a certain batch was found to contain double the dosage as found in a single pill. The warning from the FDA is as follows:
ETHEX Corporation notified health care 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. Opioids such as morphine have life-threatening consequences if overdosed. Consequences can include respiratory depression (difficulty or lack of breathing), and low blood pressure. 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. If consumers have any questions about the recall, they should call their physician, pharmacist, or other health care provider.
Read the MedWatch 2008 safety summary, including a link to the firm’s press release regarding this issue at:
This “double thickness” issue also prompted the massive Digitek recall earlier this year. The heart drug was recalled after a wide range of disturbing side effects were noted in patients, including low blood pressure, reduced heart rate and death.
Obviously, double coated morphine has the potential to cause similar injuries in users. If you have noticed any of the side effects listed above after taking morphine, it is extremely important that you file a report with the FDA.
Furthermore, if you have been seriously injured as a result of taking this defective product, you may have rights against the drug manufacturer. To speak with a defective product attorney, please call (856) 833-0600 in NJ or (215) 567-2380 in PA or fill out the free case evaluation form on the left side of the page.
You will be contacted immediately for a free case evaluation.