Recalls

Morphine drug recalled due to risk of overdose

A nationwide recall of one lot of the potent painkiller injection Hydromorphone has been issued because the syringe system may contain more of the drug than indicated on the label. Hydromorphone is an opioid pain medication that if overdosed can cause respiratory depression (or slowed or suspended breathing), low blood pressure, and reduced heart rate including circulatory collapse, all of which can cause death.

The recall involves one lot of Hydromorphone Injection, USP, 1 mg/mL (C-II), 1 mL fill in 2.5 mL Carpuject, NDC 0409-1283-31. The product is a prefilled glass cartridge for u se with the Carpuject Syringe system. The affected lot number is 07547LL, and the expiration date is July 1, 2013. It was distributed between September and October 2011. It was initially distributed to wholesalers and a limited number of hospitals in a limited number of hospitals in Alaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Indiana, Louisiana, Maryland, Massachusetts, Minnesota, Missouri, Mississippi, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Washington, and Wisconsin.

The recall was issued because of two reported complaints that a single Carpuject, or pre-filled syringe system, contained more than the 1 mL labeled fill volume.

Hydromorphone is a very potent centrally acting analgesic drug in the opioid class. It is a derivative of morphine and is considered a narcotic. It is used to relieve moderate to severe pain and severe, painful dry coughing. It is becoming more popular in the treatment of chronic pain and is considered 6-8 times stronger than morphine.

Healthcare facilities have been told what measures to take. Any side effects with this or any other drug should be reported to the Food and Drug Administration MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/report/htm.

Source: FDA