Hospira Sodium Chloride Injection Recall Issued Due to Brass Particles
A customer has found brass particles in syringes of sodium chloride distributed by Hospira, leading to a nationwide recall due to the potential risk that such contamination could cause severe injury, liver failure or death.
A Hospira 0.9% Sodium Chloride injection recall was announced on March 29, after at least one report was received of particulate matter contamination.
Although no injuries have been associated with the recalled injections, Hospira warns that the brass particles could cause a number of health problems, from delays in therapy, occlusion of small blood vessels, or copper toxicity, which can lead to hemolysis and liver toxicity. This can cause hepatic necrosis, the death of liver tissue, which can be fatal.
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The recall affects one lot of 0.9% Sodium Chloride Injection, USP, 1,000 mL, Flexible Container, with NDC 0409-7983-09. The recalled injections have a lot number of 25-037-JT, which may be followed by a -01 or -90. The injections have an expiration date of January 1, 2015. The shots were distributed between January and March of this year.
The recall is the second this year for Hospira involving an injection drug. In January the company issued a Lactated Ringers and 5% Dextrose injection recall due to mold contamination.
The company also received a warning letter from the FDA in February, due to problems discovered at a medical device manufacturing plant. FDA investigators cited the company for failing to properly handle complaints, medical device reporting and supplier quality problems.
The company says it is investigating the cause of the brass particle contamination and is urging any customers with the recalled injections in their inventory to stop use and distribution, quarantine the product immediately, and contact Stericycle by calling (888) 480-2853 to arrange for the product’s return.
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