Recalls

Morphine injections recalled due to overdose risk

One lot of morphine sulfate injection made by Hospira, Inc., is being recalled because a customer reported finding two syringes containing more of the drug than stated on the label. Morphine is an opioid pain medication that if overdosed could have life-threatening consequences. Patients who are administered too much of the drug could suffer respiratory depression (slowed breathing or suspension of breathing), and low blood pressure.

The recall involves Morphine Sulfate Injection USP, 4 mg/mL (C-11), 1 mL fill in 2.5 mL Carpuject, NDC 0409-1258-30. The affected lot number is 10830LL and the expiration date is April 1, 2013. Morphine Sulfate Carpujects 4 mg/mL are packaged in Slim-Pak tamper detection packages with each box containing 10 Carpujects. The affected lot was distributed in January 2012 to wholesalers and a limited number of hospitals in Arizona, Colorado, Hawaii, Illinois, Indiana, Michigan, Minnesota, Ohio, Texas and Virginia.

No reports of adverse events related to the problem have been reported. Hospira believes the incident is an isolated event, and has launched an investigation to determine the root cause and preventive actions. Consumers should contact their physician or health care provider if they have experienced any problems that may be related to taking or using this product.

Distribution centers and health care facilities with existing inventory of the recalled product should stop use and distribution of the medication and quarantine it immediately. Returns and replacements can be arranged by calling Stericycle at 1-888-912-7088. For medical inquiries, contact Hospira Medical Communications at 1-800-615-0187. This phone line will remain open 24 hours a day, seven days a week.

Any side effects from this or any other medication should be reported to the Food and Drug Administration (FDA) MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.

Source: FDA