0.9 Percent Sodium Chloride Injection, USP, 250 mL VisIV Container by Hospira: Recall - Particulate Matter

AUDIENCE: Pharmacy, Risk Manager

ISSUE: Hospira announced a voluntary nationwide recall of one lot of 0.9% Sodium Chloride Injection, USP, 250 mL VisIV flex container (NDC 0409-7983-25, Lot 45-110-C6, Expiry 1MAR2016) to the user level due to one confirmed customer report of particulate in a single unit. The foreign particle was confirmed by Hospira as human hair free-floating within the solution. To date, Hospira has not received reports of any adverse events associated with this issue for this lot.

Injected particulate material may result in localized inflammation, phlebitis, allergic reaction, granuloma formation or microembolic effects (IV only) and/or low-level allergic response. Capillaries which may be as small as the size of a red blood cell, approximately seven microns in diameter, may become occluded. Patients with preexisting condition of trauma or other medical condition that adversely affects the microvascular blood supply are at an increased risk.

BACKGROUND: This lot was distributed nationwide from December 2014 through January 2015. Hospira has initiated an investigation to determine the root cause and corrective and preventive actions.

RECOMMENDATION: Anyone with an existing inventory of the recalled lot should stop use and distribution and quarantine the product immediately. Customers should notify all users in their facility. Customers who have further distributed the recalled product should notify any accounts or additional locations which may have received the recalled product and instruct them if they have redistributed the product to notify their accounts, locations or facilities to the consumer level. 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. For additional assistance, call Stericycle at 1-888-714-5079 between the hours of 8 a.m. to 5 p.m. ET, Monday through Friday.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the press release, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm436871.htm