Persistent Particulates Result in Latest Hospira Recall
Hospira conducted its fourth recall in roughly two months due to contaminated products, leading to another quality headache for the injectables giant.
Hospira said it is recalling a lot of Lactated Ringers and 5 percent Dextrose Injection, USP, 1000 ml, Flexible container. The company received a customer complaint that a particulate indicative of mold was found in the solution of the primary container.
An issue with the manufacturing process made the container prone to puncture, and the drugmaker worked to resolve the problem, spokesman Daniel Rosenberg said. He declined to say which plant manufactured the affected lot.
Intravenous injection of a non-sterile product could create several adverse health risks, including organ failure and life-threatening infections, Hospira said. So far the company hasn’t received any adverse event reports connected with the lot, and hasn’t identified any quality issues with the lot’s retention samples.
The product, distributed from December 2013 to February, is intended to replace extracellular losses of fluid and electrolytes.
Hospira has been beset with particulate recalls over the past couple months. The latest occurred earlier this month when a customer found particulates in a vial of 0.5 percent Marcaine painkiller. In May, discoloration in a vial prompted a recall of the heart disease drug dobutamine. That same month, the drugmaker recalled a lot of the blood pressure drug labetalol HCl injection because of visible particles floating in the solution.
Hospira has been working to address its quality issues, and touted the FDA’s decision to upgrade the status of its troubled Rocky Mount, N.C., plant earlier this year as progress. The agency allowed Hospira to start using the facility to manufacture new products, a positive sign for the plant that was warned in 2010 for lax quality control and particulate issues.
The latest recalls haven’t impacted the company’s overall remediation efforts, Rosenberg said.
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