Hospira issued a voluntary recall of one lot of Preservative-Free Bupivacaine HCl Injection after one confirmed customer complaint of orange and black, visible particles embedded and free floating within a single-dose glass teartop vial.
According to a FDA press release, the particles were identified as iron oxide, and the recall is being carried out to the user level in both human and veterinary sectors.
Injected particulate may result in local inflammation, low-level allergic or immune responses, granuloma formation or mechanical irritation of tissue, in particular in patients allergic or sensitive to iron oxide. In addition, therapy may be delayed if observation of particulate is not made until the point of care, the press release explained.
The lot was distributed from July 2014 to September 2014. Hospira has not received reports of any adverse events associated with this issue for this lot to date. They are working with their glass supplier and has initiated an investigation to determine the root cause and corrective and preventive actions.
