Hospira Issues Recall Due to Mold Contamination
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
Mastering Antibody-Drug Conjugates
December 19th 2024In this episode, we explore BIOVECTRA’s capabilities in antibody-drug conjugate (ADC) manufacturing, from complex conjugation chemistry to synthesis of highly potent payloads. We’ll also showcase how BIOVECTRA’s extensive experience in complex chemistries and specialized small molecule manufacturing gives them a unique perspective, strengthening their approach to ADC production and ensuring clients receive custom solutions across all project stages.
Shilpa Medicare Launches ‘Hybrid CDMO’ at DCAT Week 2025
March 17th 2025This model is being positioned by Shilpa as a dual approach that offers comprehensive discovery, clinical, and commercial outsourcing services in addition to commercially ready, “off-the-shelf” novel formulations for b2b licensing.
