April 26, 2013
Hospira has voluntarily recalled one lot (Lot# 05-201-JT may be followed by -01, expiration date of May 1, 2013) of sodium chloride 0.9% 100 mL flexible containers for injection (NDC 00409-7984-23) due to one customer report of four separate single particulates in four different containers. The particles were confirmed as fibers from cotton, nitrocellulose, nylon, and polyester.
Injection of solutions with particulate could result in a generalized allergic response, local inflammation, or phlebitis. Embolism of the particulate matter to other parts of the body is also possible. No adverse events of the affected product have been reported to date.
The affected product was distributed to multiple states between May 2011 and August 2011. Hospira recommends stopping use and distribution, and quarantining the product until it can be returned. Call Stericycle at 1-888-597-9582 (Monday-Friday, 8 am-5 pm EST) to arrange product return. Contact Hospira Medical Communications at 1-800-615-0187 with questions related to the recall. Adverse events or side effects may be reported to FDA’s MedWatch Safety Information and Adverse Event Reporting Program online at http://www.fda.gov/MedWatch/report.htm.
Additional information is available at the following links:
- MedWatch Alert:
- Company Press Release:
April 26, 2013; University of Utah, Drug Information Service. Copyright 2013, Drug Information Service, University of Utah, Salt Lake City, UT.