Hydromorphone Hydrochloride Injection Recall

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Posted: Wednesday, May 16, 2012 1:26 PM

On May 12, 2012, Hospira, Inc. announced it is initiating a voluntary user level recall of one lot of Hydromorphone Injection, USP, 1 mg/mL (C-II), 1 mL fill in 2.5 mL Carpuject™, NDC 0409-1283-31, due to two reported complaints of a single Carpuject containing more than the 1 mL labeled fill volume.

Opioid pain medications such as Hydromorphone have life-threatening consequences if overdosed. Those consequences can include respiratory depression (slowed breathing or suspension of breathing), low blood pressure and reduced heart rate including circulatory collapse.

The affected product is a prefilled glass cartridge for use with the Carpuject Syringe system.

The affected lot was distributed in September - October 2011. It 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.

Hospira is undertaking this recall in consideration of the potential for safety issues if the product is administered to patients

For More information, please see the FDA's Press Release concerning the recall.