Hospira recalls one lot of hydromorphone injection

May 14, 2012
From staff reports
From staff reports

Hospira is voluntarily recalling one lot of hydromorphone injection, USP, 1 mg/mL (C-II), 1-mL fill in 2.5-mL Carpuject, NDC 0409-1283-31, after complaints that a single Carpuject contained more than the 1-mL labeled fill volume, according to a press release posted on the FDA website.

Hospira is voluntarily recalling one lot of hydromorphone injection, USP, 1 mg/mL (C-II), 1-mL fill in 2.5-mL Carpuject, NDC 0409-1283-31, after complaints that a single Carpuject contained more than the 1-mL labeled fill volume, according to a press release posted on the FDA website.

“The affected product is a prefilled glass cartridge for use with the Carpuject Syringe system. The affected lot number is 07547LL. The expiration date is July 1, 2013,” the statement said.

The affected lot was distributed last September and October, initially to wholesalers and hospitals in Alabama, Alaska, 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 has not received any reports of adverse reactions related to this issue for this lot. The company is investigating to determine the cause and is taking preventive actions.

Anyone with existing inventory should not use or distribute the product and should call Stericyle at 888-912-7093 to arrange for return of the product. Replacement product from other lots is available. Customers can send their DEA 222 form to Hospira (1635 Stone Ridge Drive, Stone Mountain, GA 30083) to order replacement product.

Symptoms of overdose of opioid pain medications can include respiratory depression, low blood pressure, and reduced heart rate, and can be life-threatening, the release said.