Hospira has issued a voluntary nationwide user-level recall of one lot of lactated ringers and 5% dextrose injection, USP, 1000 mL, flexible container, NDC 0409-7929-09.
The product is used as a source of water, electrolytes, and calories or as an alkalizing agent. The lot number is 05-019-JT, with an expiration date of May 1, 2013.
A customer report that a spore-like structured particulate, consistent with mold, noted in the solution has been confirmed. Hospira has not received reports of any adverse events associated with this issue for this lot, and it has not identified any quality issues with retention samples for this lot.
The affected lot was distributed nationwide between June 2011 and January 2012 to wholesalers/distributors, hospitals, and pharmacies.
If contaminated solution is used on a patient, it may cause thrombosis, phlebitis, bacteremia, sepsis, septic shock, and/or endocarditis, or result in a fatal infection in a broad array of patients.
Anyone with an existing inventory should stop use and distribution, quarantine the product immediately, and call Stericycle at 1-888-965-5798 between the hours of 8 am and 5 pm EST, Monday through Friday, to arrange for the return of the product. Replacement product from other lots is available.
Any adverse reactions or quality problems experienced with the use of this product may be reported to FDA’s MedWatch Adverse Events Program:
· Online: www.fda.gov/medwatch/report.htm
· Regular mail: postage-paid, pre-addressed Form FDA3500 available at www.fda.gov/MedWatch/getforms.htm
· Fax: 1-800-FDA-0178
For medical inquiries, contact Hospira Medical Communications at 1-800-615-0187, which is available 24 hours a day, 7 days a week.