Posted 03 September 2013
By Alexander Gaffney, RF News Editor
Biopharmaceutical manufacturer Hospira has found itself in something of a hairy situation-literally.
In a 30 August 2013 announcement, the company said it was voluntarily initiating a voluntary 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 is underway.
Regardless of the presence of the contamination, Hospira said the potential for it to physically affect a patient would be "minimal", noting that a 0.22 micron air eliminating filter should be used in the administration of the product.
"In the event that the particulate was not observed, the particulate identified theoretically would not be able to pass through the intravenous catheter or an intravenous infusion," Hospira explained. "It is also unlikely that the particulate could block the infusion of solution into the patient."
If, however, the hair were to pass through the filter (Hospira speculated that perhaps a piece of the hair might), it could cause local inflammation, a low-level allergic response, and/or phlebitis (inflammation of the veins).
The recall comes just months after Hospira announced that FDA inspectors had found its Irungattukottai, India manufacturing facility to have "significant violations" of current good manufacturing practices, resulting in a Warning Letter being sent to it on 28 May 2013.
In its letter to Hospira, FDA explained that many of the company's practices at the facility could have resulted in products being contaminated. "We are concerned that your environmental excursion investigators or other quality oversight did not uncover the potential for use of gloves whose sterility was compromised," investigators wrote of one particularly notable incident.
Further compounding problems seen in the letter was FDA's observation that many problems witnessed at the facility were also observed in an earlier February and March 2013 inspection of the company's Rocky Mount facility in North Carolina. That same facility had already been the subject of a deficient inspection finding in 2010, also earning Hospira a Warning Letter.
Regulators called for a global investigation by the company into the alleged problems.
Hospira Recall Statement