One lot of Hospira’s Lactated Ringer’s and 5% Dextrose Injection, USP, 1000 mL, Flexible Container, NDC 0409-7929-09 is being recalled 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, was noted in the solution.
When a primary container within an overwrap has a leak, there is an open pathway for contamination of the fluid. The overwrap is not sterile, and any fluid which may have leaked out may become trapped within the overwrap and has the potential to be reintroduced into the primary container. If contaminated solution is used on a patient, critical patient harm may result. Injections of mold could potentially lead to septicemia (blood stream infections), which in a worst-case scenario may have the potential to progress to septic shock, which may be life threatening. Signs and symptoms could include injection site reactions, fever, shortness of breath, fast heart rate and feeling generally ill with nausea and vomiting.
The impacted product is identified by NDC number 0409-7929-09, Batch number 12-160-JT followed by either 01 or 90, expiration date 1DEC2013, and product description Lactated Ringer’s and 5% Dextrose Injection, USP, 1000 mL. The affected lot was distributed in all states with the exception of Alaska, between the dates of January 2012 and June 2012.
See the Recall