Hospira Issues Voluntary Recall of Dextrose Injection

Hospira Issues Voluntary Recall of Dextrose Injection

Hospira Issues Voluntary Recall of Dextrose Injection

On October 5, 2012, the Food and Drug Administration announced that Hospira, Inc. issued a “voluntary user-level” recall for certain Lactated Ringer’s and the Dextrose Injection, USP, 1000 mL, Flexible Container.  Hospira, Inc. is the largest provider of injectable drugs and other specific technologies in the world.  

The voluntary nationwide recall was announced after a customer reported there was a leak in the main container between the cobra cap and the fill-tube seal.  The customer also noted a spore-like substance in the solution.  The FDA reports that such a leak creates a direct pathway for contamination of the fluid.  

Because the main overwrap is not sterile, any fluid that leaks from the primary container can become unsterile as well.  The FDA reports that contamination to the injectable fluid puts the patient in danger.  If the patient injects a fluid containing mold, they are in danger of contracting septicemia—infections within the blood stream.  Septicemia, in the worst cases, can lead to a life-threatening condition called septic shock.  Signs of septicemia include reactions at the injection site, fever, shortness of breath, a fast heart rate, nausea, vomiting, and just feeling ill overall.  

The infected product has an NDC number of 0409-7929-09 and a batch number of 12-160-JT possibly followed by 01 or 90.  The Lactated Ringer’s and 5% Dextrose Injection, USP, 1000 mL have an expiration date of December 1, 2013.  The products were distributed everywhere in the United States except for Alaska from January 2012 to June 2012.  

Hospira announces that no adverse reactions to the batch have been reported so far.  The company has not received any infected samples either.  However, the company is recalling the product as a precautionary step.  

If you have a recalled product, you need to make sure the product stays sealed and call Stericycle at 1-877-650-7688.  You will receive instructions on returning the product and receive a replacement as well.  

Source: U.S. Food and Drug Administration




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