Baxter Recalls IV Solutions Due to Particles

July 25, 2014

Baxter is voluntarily recalling four lots of intravenous solutions in response to customer complaints of plastic and fiber particles in the product, its fourth recall this year related to particulates.

The drugmaker said it is pulling three lots of 0.9 percent sodium chloride 100 ml and a lot of highly concentrated potassium chloride injection 50 ml.

Baxter received four complaints over six months from customers that saw the particles during a visual inspection.

While the drugmaker hasn’t received reports of any adverse events due to the affected lots, it stresses that particulate matter could create health problems. “The presence of particulate foreign matter may elicit inflammatory and allergic responses, both chronic and acute, and may be life threatening,” Baxter said.

The drugmaker is investigating the cause of the problem, but declined to elaborate.

Baxter has recalled products due to particulates before. Earlier this year it called back a single lot of dialysis solution contaminated with mold. It also recalled a lot of sodium chloride in June, and three lots of parenteral nutrition products Clinimix (amino acid in dextrose) and Clinimix E (amino acid with electrolytes in dextrose with calcium) in January due to particulates.

The drugmaker did not return a request for comment as of press time.

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