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Puncture in container and overwrap cause leak in intravenous solution, leading to recall by Hospira.
Hospira, Inc. has announced 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, Lot 35-118-JT, Expiry 1NOV2015.
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.
In a statement announcing the recall, Hospira reports that the company has investigated and determined the root cause of the event; the company has implemented corrective actions to address the issue. The lot was distributed nationwide from December 2013 through February 2014 to hospitals, clinics, wholesalers, and distributors. The recall is being conducted as a precautionary measure, Hospira reports.
Hospira says the company 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.
Source: FDA and Hospira