Hospira Recalls One Lot of Overfilled Hydromorphone Hydrochloride Injection

Risks of a decrease in respiratory function, drop in blood pressure, and slowed heart rate were all reasons for Hospira to issue a recall of one lot of Hydromorphone Hydrochloride injections on August 15, 2012. The injections had been labeled to contain 1 mL  fill volume; however, when one consumer reported a injection that had been filled with more than this amount, Hospira recalled the lot to avoid harm to patients. According to the manufacturer, syringes that contain more than the dose labeled can be a threat to consumers and possibly result in an overdose, serious side effects and even a circulatory collapse.

The recalled product includes Hydromorphone Hydrochloride Injections of 1 mL  in 2.5 mL Carpuject™. These products were recalled from Lot 12720LL that was released between March – May 2012. The products may also be identified by an expiration date of December 1, 2013.

The recall was implemented to avoid the risk of accidental injection of higher amounts of Hydromorphone Hydrochloride in patients. Anyone who is in possession of the recalled product should not use the injections. Instead, the U.S. Food and Drug Administration asks that the product be quarantined, and that patients contact Stericycle by calling 1-866-873-0312, where the product should be returned and replaced. If you have any questions about the recall, do not hesitate to call Hospira Medical Communications at 1-800-615-0187.

Patients who suffer from an adverse reaction upon the event of injecting a recalled product should call the FDA MedWatch Program. Go to http://www.fda.gov/medwatch/report.htm to submit a form with your information or visit http://www.fda.gov/Safety/Recalls/ucm315671.htm for more details on how to report your case.

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