Sodium Chloride Injection Recalled Due to Particulate Matter Complaints

Hospira is voluntarily recalling 1 lot of its 0.9% Sodium Chloride Injection USP 250 mL at the user level following a confirmed report of particulate, identified by the manufacturer as human hair, in a single unit.

In addition to investigating the potential cause of the contamination, Hospira is considering the best course of action to correct this issue and prevent future incidents. To date, there have been no reports of any adverse events associated with this issue.

The recalled product, which was distributed nationwide from September 2014 through November 2014, has a lot number of 44-002-JT and an expiration date of August 1, 2016.

Those with an existing inventory of the recalled lot should stop use and distribution, and quarantine the product immediately. Hospira has notified its customers of the recall by letter and is arranging for impacted product to be returned to Stericycle in the United States. Those who have further questions regarding this recall should call Stericycle at 1-877-877-0164 between 8 a.m. and 5 p.m. Eastern Standard Time, Monday through Friday.

In addition to contacting their health care providers, patients who have experienced adverse reactions to this product should report them to the FDA’s MedWatch Adverse Event Reporting program. Patients can submit the form online at www.fda.gov/medwatch/report.htm, download it at www.fda.gov/MedWatch/getforms.htm, or call 1-800-332-1088 to request it. Completed paper forms can be returned to the address on the pre-addressed form or faxed to 1-800-FDA-0178.