Hospira Issues A Voluntary Nationwide Recall Due To Particulate

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Hospira, Inc., headquarters in Lake Forest, Ill, is a world leading provider of injectable drugs and infusion technologies.

In August of 2012, Hospira began a voluntary nationwide recall of one lot of 0.9% Sodium Chloride Injection, USP, 100 mL, Flexible Container, NDC 0409-7984-23. The recall was initiated because of a confirmed customer report about four separate particulate issues being identified in four individual flexible containers. The four particles were polyester fiber, nylon fiber, cotton fiber, and nitrocellulose fiber.

The product was distributed to wholesalers/distributers, hospitals and pharmacies within these 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.

The U.S. Food and Drug Administration was aware of the recall. The company investigated to determine the cause of the problem.

Possible Adverse Effects

The product is used as a source of water and electrolytes. If a patient is injected with solution containing particulate matter, then he or she may face local inflammation, phlebitis, an allergic response, embolize to organs in the body, and/or granulomatous formation in the lungs is possible.

Reporting A Problem

Individuals with inventory should stop use and distribution. The product should be quarantined immediately. Call Stericycle at 1-877-597-9582 (8am-5pm ET, M- F), to arrange for the return of the product. Replacement product from other lots is available.

Please contact Hospira at 1-800-441-4100 (8am-5pm CT, M-F) to report adverse events or product complaints or 1-800-615-0187 (available 24 hours a day/7 days per week) to report medical inquires.

Individuals with any reactions or quality problems experienced with the use of the product can be reported by using the following procedures:

Online: www.fda.gov/medwatch/report.htm
Regular mail: use postage-paid, pre-addressed Form FDA3500 available at www.fda.gov/MedWatch/getforms.htm
Fax: 1-800-FDA-0178