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FDA warns about Hospira's doubly-filled injectables

By Natalie Morrison , 28-May-2012
Last updated on 28-May-2012 at 13:21 GMT2012-05-28T13:21:30Z

The US FDA has issued a warning about Hospira’s Carpuject prefilled cartridges after batches were found containing more than twice the amount of recommended dosage.

The issue was first flagged-up when the firm received complaints from healthcare providers regarding its products containing morphine and hydromorphone. The fault was reportedly obvious by just looking at the cartridge.

It is believed the blame lies with defective filling equipment. Over 280 lots of 15 different Carpuject prefilled cartridges are now at risk.

Senior manager of global public affairs Dan Rosenburg told in-PharmaTechnologist: “We identified the root cause to be due to a manufacturing issue in the filling equipment.

“We have implemented corrective actions to prevent further occurrence and have not received any reports of adverse health events related to this issue.”

Both the US Food and Drug Administration (FDA) and Hospira have now warned medical staff to visually inspect cartridges for any sign of overfill.

No product recall has been made for fear of drug shortage.

In a statement, the FDA said: “Because pharmacists and other healthcare providers can visually identify the presence of an overfilled Carpuject prefilled cartridge, FDA is recommending that these steps be taken at this time rather than a product recall, because a recall of the affected products listed above would result in an immediate shortage.

“FDA is still evaluating whether additional steps are necessary.”

Problems

The incident is not the first bump in the road for Hospira in recent years.

In 2010, the FDA handed the company a warning letter about activities at two plants in North Carolina, US – one in Rocky Mount, one in Clayton.

Though the firm seemed well on its way to fixing the issues, this March it was forced to close its Clayton site, again citing manufacturing hiccups. The plant was re-opened this month .

When asked which site the latest problems hail from, Rosenburg told us only that the drugs “were not produced at Rocky Mount”.

Of what the latest news could mean for the firm, he said: “The financial impact isn’t material. We continue to manufacture and release product on the Carpuject line, as we have the assurance that the product we are manufacturing is safe.”

The firm recently promised to pump $375m (€290m) to fixing its problems, with CEO Micheal Ball warning it will be “a bumpy road,” but asking investors to stick with them as the issues are “very fixable”.

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