Hospira, Inc. just announced that it s recalling, at the user level, one lot of its Hydromorphone Injection over reported complaints that one of its Carpuject’s contains more than 1 mL label fill volume, the U.S. Food & Drug Administration (FDA) just announced.
Involved in the recall is Hydromorphone Injection, USP, 1 mg/mL (C-II), 1 mL fill in 2.5 mL Carpuject™, NDC 0409-1283-31. This is a prefilled glass cartridge that is used with the Carpuject Syringe system. The affected lot number is 07547LL and the expiration date is July 1, 2013.
The recalled lot was distributed during September and October 2011 and was initially distributed to wholesalers and 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.
Opioid pain medications such as Hydromorphone, can have serious and life-threatening consequences if overdosed. Consequences can include respiratory depression (slowed breathing or suspension of breathing); low blood pressure; and reduced heart rate, including circulatory collapse.
Hospira has not received any reports of adverse events related to this issue for this lot, to date, and has implemented an investigation to determine the root cause of the problem; and to take preventive actions. Hospira advises consumers to contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.
Also, those with an existing inventory are advised to stop use and distribution; to quarantine the product immediately; and to call Stericycle, toll-free, at 1.888.912.7093 to arrange for the return of the product. Replacement product from other lots is available. Customers can also send their DEA 222 form to Hospira at 1635 Stone Ridge Drive, Stone Mountain, Georgia, 30083 to order replacement product.
Hospira Medical Communications at also be reached, toll-free, at 1.800.615.0187, which is available 24 hours a day, seven days a week.
Adverse reactions or quality problems experienced with the use of this product may also 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 by fax at 1.800.FDA.0178.