Hospira had notified the public last August that it initiated a voluntary nationwide user-level recall of one lot of 0.9% Sodium Chloride Injection, USP, 100mL, Flexible Container, NDC 0409-7984-23. This action was taken due to one confirmed customer report where four separate particulate issues were identified in four individual flexible containers. The four single particles were identified as polyester fiber, nylon fiber, cotton fiber, and nitrocellulose fiber. Hospira is investigating the root cause.
The affected lot number is 05-201-JT (the lot number may be followed by a -01). The affected product has an expiration date of May 1, 2013 and was distributed within the U.S. between May 2011 and August 2011 to wholesalers/distributors, hospitals, and pharmacies. The product was distributed to the following U.S. states: Alaska, Alabama, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, North Carolina, North Dakota, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming.
If solution containing particulate matter is used on a patient, this may result acutely in local inflammation, phlebitis, and/or generalized low-level allergic response to the particulate and/or embolize to other organs in the body. Chronically, following sequestration, granulomatous formation in the lungs is possible. The FDA advises that anyone with an existing inventory should stop use and distribution, quarantine the product immediately, and call Stericycle at 1-888-597-9582 between 8am-5pm ET, Monday-Friday, to arrange for the return of the product. Replacement product from other lots is available.
For more information visit http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm349622.htm.