Hospira Injections Recalled for Potential Overdose Risk

injection recallThe U.S. Food and Drug Administration (FDA) (www.fda.org) has posted a press release from drug manufacturer Hospira Inc. regarding a safety issue with its opiate pain relief injection, hydromorphone hydrochloride. The recall involves one lot of the 2 MG/ML, (C-II) 1 ML Fill In 2.5 ML which uses the Carpuject syringe injection system. The Carpuject cartridge contains more than the intended fill volume, leading to the risk of a health care provider dosing the patient with too much medication.

Opiate pain relief medications pose life-threatening dangers if overdosed, including low blood pressure, slowed or suspended breathing and reduced heart function leading to circulatory collapse. The affected cartridges are thought to contain twice the amount of medication indicated on the label.

Quality Issues Plague Hospira

Hospira, based in Lake Forest, Illinois, is a leading generic provider of infusion treatments and injectable drugs. Quality issues have plagued the company for some time now, with the company receiving major violation notices for its plants in Rocky Mount and Clayton, North Carolina and in Austin, Texas.

In order to address the compliance violations and issues, Hospira increased its investment budget for the plants and turned to outside consultants to recommend changes. Two of the three plants have undergone maintenance upgrades and the third is awaiting an FDA inspection report. The violations have forced the FDA to monitor the company’s manufacturing plants more closely. The FDA has inspected Hospira’s plants several times since the beginning of 2012.

In May 2012, Hospira notified health care professionals of the overfill situation with the pre-filled Carpuject syringe system. At the time, it was determined that notification was sufficient and that health care professionals would easily be able to identify the product. However, given the severity of the potential adverse effects of using the product, Hospira has now deemed it prudent and necessary to voluntarily recall the complete lot.

To date, no adverse events have been reported to the FDA or Hospira, related to use of the product.

According to the FDA, the affected lot number is 12720LL. The expiration date of the lot is December 1, 2013 and was distributed March through May 2012.

Hospira recommends quarantine of any existing inventory. The product may be returned to Hospira and replacement product is available to those affected.