Hospira Recalls Saline Solution Over Potential Contamination

hospira-saleen-contamination-recallHospira just issued a recall of some of its sodium chloride injection containers over concerns about potential contamination with metal particles.

A confirmed report was received that the flexible sodium chloride injection container contained a number of gray-brown particles, said MassDevice. The particles were identified as copper, lead, and zinc. The product, a water and electrolytes infusion system, was sold in 1000mL flexible containers.

Hospira is warning its customers to pull any containers of sodium chloride injection containers purchased from January 2013 to March 2013, said MassDevice. The drug maker is also requesting that customers return any recalled products with a January 1, 2015 expiry date in exchange for replacement products from other, uncontaminated lots, said MassDevice. The U.S. Food and Drug Administration (FDA) sent out a warning letter to consumers on March 29 advising of the potential contamination. In a statement, Hospira indicated that it is investigating the cause of the contamination, according to MassDevice.

Late last year, Hospira was hit with a federal warning over its Costa Rican manufacturing facility. The FDA warning letter followed a series of quality problems on which we had been writing. The Costa Rican facility manufacturers most of Hospira’s infusion pumps, said Reuters previously.

The FDA cited ongoing problems with Hospira’s Plum brand infusion pump, which the firm recalled in February 2011. That recall involved the pump’s alarm. Hospira received alarm failure complaints even following a component redesign, said the agency in its letter.

We also previously recently wrote that Hospira, Inc. announced a recall of its Hydromorphone Injection due to overdose concerns. That recall involved one lot of Hydromorphone Injection and followed a reported complaint of a single Carpuject containing more than the 1 mL labeled fill volume. Opioid pain medications such as Hydromorphone have life-threatening consequences if overdosed, including respiratory depression (slowed breathing or suspension of breathing); low blood pressure; and reduced heart rate, including circulatory collapse.

Prior to that, Hospira Propofol was recalled, nationwide, for a vial defect involving three lots of Propofol Injectable Emulsion in which visible particles embedded in the glass were discovered at the user level. This defect could cause the drug to come into contact with the embedded particles, which might become dislodged into the solution. In the event particulate matter is injected into a patient, patient injury requiring medical intervention could occur. Risks include tissue necrosis in one or more organs that could result in stroke, myocardial infarction, respiratory failure, and loss of renal and hepatic function.

Hospira expanded a March 2010 recall of its Propofol Injectable Emulsion 1% and Liposyn (Intravenous Fat Emulsion) products because some recalled containers might have contained particulate matter primarily made up of sub-visible inert stainless steel particles. And, in 2010, Hospira also recalled its Symbiq Infusion Systems One-Channel and Two-Channel Infusers, a recall deemed a Class I by the agency because of the potential for the device to fail to detect air in a line at the end of an infusion, which could result in the delivery of air to the patient, which could lead to serious injury or death.

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