Hospira Initiates Voluntary Recall of One Lot of Lactated Ringers/Dextrose

Hospira, Inc. reported on July 10, 2014, that it is initiating a voluntary nationwide user-level recall of one lot of lactated ringers and 5% dextrose injection, USP, 1000-mL, flexible container. This action is due to one confirmed customer report where particulate was identified within the solution of the primary container. The particulate was identified as a filamentous-like structured particulate indicative of mold. Analysis of the primary container and overwrap indicated a puncture in the same physical location, causing the primary container to leak.

The product is indicated for parenteral replacement of extracellular losses of fluid and electrolytes, with or without minimal carbohydrate calories, as required by the clinical condition of the patient. The product is packaged in 1000-mL flexible containers, 1 container per overwrap, and 12 overwrapped containers in each case. This lot was distributed nationwide from December 2013 through February 2014 and was distributed to hospitals, clinics, wholesalers, and distributors. This recall is being conducted as a precautionary measure.

Hospira has not received reports of any adverse events associated with this issue for this lot to date and has not identified any quality issues with retention samples for this lot. Hospira has investigated and determined the root cause of the event and has implemented corrective actions to address this issue.

In general, a defect in a container leading to a leak may create a breach in sterility since an open pathway exists for contamination of fluid. If the leak is not detected, and the solution becomes contaminated and it is not identified prior to administration, there is potential that contaminated solution could be administered to the patient.

Source: Hospira and  FDA


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