The U.S. Food and Drug Administration (FDA) recently announced the nationwide voluntary recall of a lot of Hospira, a hydromorphone hydrochloride injection. According to the announcement, this recall has been initiated due to two reports of single drug delivery cartridges containing more than the 1 mL volume of the labeled medication.
These Hospira cartridges are part of the Carpuject Syringe System, which consists of prefilled glass cartridges that are loaded into a syringe holder to deliver the drug. This system is intended to provide an easy, safe, convenient, and time-saving method of delivering this medication.
However, the FDA explains that opioid pain medications such as hydromorphone have life-threatening overdose consequences which include the following:
- Respiratory depression-slowed or suspended breathing
- Low blood pressure
- Reduced heart rate and circulatory collapse
The faulty lot was distributed from September to October of 2011 and has the lot number 07547LL. The expiration date for this lot is July 1, 2013. The medication was first distributed to wholesalers and some hospitals in the following locations: 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.
Although the drug’s manufacturer, Hospira, Inc., says they have not yet received any adverse event reports related to this lot defect, they have begun an investigation to coincide with this recall. Through this investigation, the manufacturer hopes to determine the root cause of this defect, as well as determine any preventative actions that need to take place.
The recall announcement explains that anyone who experiences problems that may be related to this medication is encouraged to contact their physician or healthcare provider to report these issues. Furthermore, anyone possessing this medication is instructed to stop using or distributing it and to quarantine what they have.
Individuals are then instructed to call Stericycle at 1-888-912-7093 to arrange the return of the product. The FDA explains that replacements from safe lots of this medication are available to customers and can be received by sending their DEA 222 form to Hospira, 1635 Stone Ridge Drive, Stone Mountain, GA 30083.