Hospira, Inc. is recalling morphine injections because the syringes may be over-filled, the U.S. Food & Drug Administration just announced.
The recall involves one lot of Morphine Sulfate Injection USP, 4 mg/mL (C-II), 1 mL fill in 2.5 mL Carpuject, NDC 0409-1258-30. The action was prompted following a customer report of two Carpujects syringes containing more than the 1 mL labeled fill volume.
Opioid pain medications such as morphine can have life-threatening consequences if too much is taken. Reactions include respiratory depression (slowed breathing or suspension of breathing) and low blood pressure.
The recalled Hospira injection is a prefilled glass cartridge that is used as part of the Carpuject™ Syringe system. The lot number involved is 10830LL and the expiration date is April 1, 2013. Morphine Sulfate Carpujects 4 mg/mL are packaged in Slim-Pak® tamper detection packages; each box contains 10 Carpujects (NDC 0409-1258-30).
The recalled morphine lot was distributed in January 2012 and was initially distributed to wholesalers and a limited number of hospitals in Arizona, Colorado, Hawaii, Illinois, Indiana, Michigan, Minnesota, Ohio, Texas, and Virginia.
To date, Hospira has not received any reports of adverse events related to the recalled lot and believes this to be an isolated event. Hospira said it initiated an investigation to determine the root cause and plans on implementing preventive actions.
Hospira advises consumers to contact their physician or healthcare provider if they experience any problems with the recalled morphine. Hospira also advises anyone with inventory of the recalled injection to stop its use and distribution, quarantine the product immediately, and call Stericycle, toll-free, at 1.888.912.7088 to arrange for the return of the product; replacement product from other lots is available. Customers can send their DEA 222 form to Hospira, 1635 Stone Ridge Drive, Stone Mountain, Georgia, 30083 to order replacement product. Hospira Medical Communications can be reached, also toll-free, at 1.800.615.0187, which is available 24 hours a day, seven days a week.
Adverse reactions or quality problems may be reported to the FDA’s MedWatch Adverse Events Program either online, by regular mail, or by fax: Online: www.fda.gov/medwatch/report.htm; regular mail: use postage-paid, pre-addressed Form FDA3500 available at www.fda.gove/MedWatch/getforms.htm; or toll-free Fax: 1.800.FDA.0178.
In 2010, Hospira recalled is Symbiq Infusion Systems One-Channel and Two-Channel Infusers, a recall deemed a Class I by the agency. The system is an infusion pump intended for the delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blood, and blood products through parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural, or irrigation routes. The recall was implemented because of the potential for the device to fail to detect air in line at the end of an infusion, which could result in the delivery of air to the patient, which could lead to serious injury or death.
Hospira, Inc. also expanded a March 2010, recall of its Propofol Injectable Emulsion 1% and Liposyn (Intravenous Fat Emulsion) products because some of the recalled containers might have contained particulate matter primarily made up of subvisible inert stainless steel particles.