Hydromorphone HCl injection 1mg/mL recalled due to overdose risk

One lot of hydromorphone HCI injection 1 mg/mL manufactured by Hospira (Dilaudid) is being recalled due to reports that the prefilled glass cartridges designed for use in the Carpuject Syringe system contain more than the 1mL labeled fill volume, the FDA announced in a safety alert.

The affected lot number is 07547LL, with an expiration date of July 1, 2013, and was distributed from September through October 2011.

Opioid pain medications such as hydromorphone have life-threatening consequences if overdosed, including respiratory depression, low BP and reduced heart rate including circulatory collapse, the FDA warned.

The product was 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.

Anyone with an existing inventory should stop use and distribution, quarantine the product immediately, and call Stericycle at (888) 912-7093 to arrange for the return of the product.

Health-care providers should report any adverse events associated with this product to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.

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