Regulatory Focus™ > News Articles > Recalls by Hospira Continue to Mount as Company Finds Hair, Glass, Steel and Brass

Recalls by Hospira Continue to Mount as Company Finds Hair, Glass, Steel and Brass

Posted 03 October 2013 | By Alexander Gaffney, RAC 

Sterile drug manufacturer Hospira is once again initiating a voluntary recall under the supervision of the US Food and Drug Administration-at least the third major recall in recent months due to particulate contamination.

Background

The company has been subject to a number of recalls-and a Warning Letter-in recent months.

In August 2013, Hospira issued a recall of one lot of Aminosyn, an amino acid solution administered intravenously, after a customer reported finding an "unknown foreign particle" in the injection port of the product.

That "foreign particle," Hospira explained, was human hair-a decidedly non-sterile organic addition to an injectable product that requires high levels of sterility. The company said in a statement that it has not received any reports of adverse events associated with the contamination, and that a root cause investigation was underway.

Just two weeks later, the company issued another recall for one lot of Lidocaine HCl injection after reportedly finding "dark red/black particles" which were later confirmed to be oxidized stainless steel.

In May 2013, the company notified investors that its Irungattukottai, India facility had received a Warning Letter from FDA regarding deficiencies in its current good manufacturing practices. Specifically, surfaces in the facility were un-sanitized and other unsanitary practices had been used.

Those observations were similar to ones seen at the company's North Carolina manufacturing facility as well, FDA added. Regulators said they would require evidence that the company has a global corrective action plan in place given the scope of the violations across the organization.

And two months earlier in March 2013, Hospira issued a nationwide recall for a lot of sodium chloride injection due to the presence of "Several small gray/brown particles," later determined to be a "brass particulate … containing copper, zinc and lead."

One month prior to that, Hospira recalled lots of five different products after finding visible particles embedded in the glass of injectable propofol products.

One More, This Time for Glass

Now Hospira can add one more recall to the list. On 1 October 2013, the company initiated a voluntary nationwide recall for a lot of Metoclopramide injection and two lots of Ondansetron injection.

The company said glass strands were "identified as being affixed to the inside of the vial walls," which had the potential to dislodge into the solution, potentially endangering the patient by inducing vomiting or even embolisms.

The company said it has not received any reports of adverse events, and the recall was being conducted as a "cautionary measure."


Hospira Recall Notice


Tags: Hospira, Recall

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