The FDA and Hospira announced that they are initiating a voluntary user-level recall of one lot of Lactated Ringer’s and 5% Dextrose Injection, 1,000mL, Flexible Container. This recall is due to one confirmed customer report where a leak was identified in the primary container between the cobra cap and fill-tube seal and a spore-like structured particulate, consistent with mold.
Since the overwrap is not sterile, any fluid which that may have leaked out may become trapped within the overwrap, and has the potential to be reintroduced into the primary container. Injections of mold could potentially lead to septicemia, which may have the potential to progress to life-threatening septic shock. Signs and symptoms could include injection site reactions, fever, shortness of breath, fast heart rate, and feeling generally ill with nausea and vomiting.
The affected product is Lactated Ringer’s and Dextrose 5% Injection, 1,000mL with Batch # 12-160-JT* and an expiration date of 12/1/2013. Anyone with an existing inventory should stop use and distribution, and call Stericycle at (877) 650-7688.
Lactated Ringer’s and 5% Dextrose provide electrolytes and calories and is a source of hydration. The lactate produces a metabolic alkalinizing effect.
For more information visit http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm322966.htm.