Presence of Particulate Matter Prompts Recall from Hospira

Presence of Particulate Matter Prompts Recall from Hospira
Image: Pixabay
March 22, 2016

Hospira has announced a recall for 8.4 percent Sodium Bicarbonate Injection due to the presence of particulate matter.

The recall applies to only one lot of the product, number 56-148-EV. Packaged in a single-dose glass flip top vial, the injection bears National Drug Code (NDC) 0409-6625-02 and an expiration date of 08/01/2017. It was sold in boxes of 25 vials per case.

Hospira distributed the product nationwide to wholesalers and hospitals in December 2015.

To date, the company has not received reports of any adverse events associated with this issue for this lot.

If the particulate is not observed prior to IV administration and breaks off into smaller particulates, passing through the catheter, it may result in localized inflammation or an allergic reaction. Larger particulates may block the infusion of solution, potentially resulting in a delay in therapy.

Hospira believes that the risk of an adverse event is low due to the high detectability of the particulate prior to the point of care.

Anyone with an existing inventory of the recalled lot should stop use and distribution and quarantine the product immediately. Hospira will be notifying its direct customers via a recall letter and is arranging for impacted product to be returned to Stericycle in the United States.

Customers with questions about this recall can contact Hospira by phone at (800) 441-4100 or by email at ProductComplaintsPP@hospira.com. Stericycle can be reached at (888) 965-6077.