  |
Lactated Ringers and 5 Percent Dextrose Injection, USP, 1000 ML, Flexible Containers: Recall - Due to Non-Sterility
AUDIENCE: Pharmacy, Patient, Health Professional
ISSUE: Hospira, Inc. is initiating 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. This action is due to one confirmed customer report where a spore-like structured particulate, consistent with mold, was noted in the solution. Hospira has not received reports of any adverse events associated with this issue for this lot, and has not identified any quality issues with retention samples for this lot. If contaminated solution is used on a patient, this may cause thrombosis, phlebitis, bacteremia, sepsis, septic shock and/or endocarditis, or result in a fatal infection in a broad array of patients.
BACKGROUND: The product is used as a source of water, electrolytes and calories or as an alkalizing agent and is packaged in a 1000 mL flexible container, lot number 05-019-JT, with an expiration date of May 1, 2013. The affected lot was distributed nationwide between June 2011 and January 2012 to wholesalers/distributors, hospitals and pharmacies.
RECOMMENDATION: 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 8am to 5pm EST, Monday through Friday, to arrange for the return of the product. Replacement product from other lots is available. For medical inquiries, please contact Hospira Medical Communications at 1-800-615-0187.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the Medwatch safety alert, including a link to the Firm Press Release, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm337089.htm
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
Update your subscriptions, modify your e-mail address, or stop subscriptions at any time on your Subscriber Preferences Page. You will need to use your e-mail address to log in. If you have questions or problems with the subscription service, please contact support@xxxxxxxxxxxxxxx.
This service is provided to you at no charge by U.S. Food & Drug Administration (FDA).
| This email was sent to list-fda@xxxxxxxxxxx using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420 |  |
