Hospira Issues Recall Due to Mold Contamination - - BioPharm International

ADVERTISEMENT

Hospira Issues Recall Due to Mold Contamination


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

blog comments powered by Disqus

ADVERTISEMENT

ADVERTISEMENT

AbbVie/Shire Deal Officially Off
October 20, 2014
Amgen Sues Sanofi and Regeneron over Patent for mAb Targeting PCSK9
October 20, 2014
EMA Works to Speed Up Ebola Treatment
October 20, 2014
Lilly to Close Manufacturing Facility in Puerto Rico
October 17, 2014
BioReliance Introduces New Predictive Assays
October 17, 2014
Author Guidelines

Click here