Hospira Hydromorphone Hydrochloride Recall Due to Overdose Risk

One lot of hydromorphone has been recalled by Hospira, Inc. due to reports that some vials may be overfilled, which could cause a life-threatening hydromorphone overdose. 

The Hospira Hydromorphone Hydrochloride injection recall was announced by the FDA on May 12, after Hospira received at least two reports of a syringe that was filled beyond the 1 mL volume on the label. It is similar to a recall for overfilled morphine syringes announced last month.

Hydromorphone overdoses can be fatal, as it may result in respiratory distress, low blood pressure, reduced heart rate and circulatory collapse. Although the overfilled vials have been found by consumers, there have been no reports of injury caused by an overdose.

The recall affects lot number 07547LL of Hospira Hydromorphone Injection, USP, 1 mg/mL (C-II), 1 mL fill in 2.5 mL Carpuject syringes. They have an NDC of 0409-1283-31 and an expiration date of July 1, 2013.

The affected syringes were distributed in September and October of 2011 to wholesalers and 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.

Hydromorphone is an opioid painkiller similar to morphine and OxyContin.

In mid-April, reports of overfilled Carpuject syringes led to a nearly identical morphine recall, which also affected one lot of Hospira drugs. The company says that it has initiated an investigation to determine the root cause and to decide how to prevent it from happening in the future.

In the meantime, customers with existing inventory of the affected hydromorphone syringes should stop using and distributing the recalled drugs and quarantine the product immediately. Customers can call Stericycle at (888) 912-7093 to have it returned. The company has said that replacements from lots unaffected by the recall are available.