Hospira Recalls One Lot of Lactated Ringers And 5% Dextrose Injection

Hospira Recalls One Lot of Lactated Ringers And 5% Dextrose Injection

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January 27, 2013

Hospira, Inc.has announced it 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.

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.

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.

Hospira is investigating to determine the root cause.

For medical inquiries, please contact Hospira Medical Communications at 1-800-615-0187. This phone number is available 24 hours a day, seven days a week.

Any adverse reactions or quality problems experienced with the use of this product may be reported to the U.S. Food and Drug Administration’s (FDA) MedWatch Adverse Events Program either online, by regular mail or by fax.

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

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA).

Source: FDA

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Category: Drug Recalls

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