Baxter Recalls More Products Due to Particulates

Baxter continues to be plagued with particulate problems, recalling two lots of a dialysis solution and a lot of saline solution that is currently in short supply.

The drugmaker said it is voluntarily recalling two lots of dianeal low calcium peritoneal dialysis solution with 2.5 percent dextrose 5000 ml. The FDA issued an alert the same day regarding the recall of a single lot of the saline solution, 0.9 percent sodium chloride injection, USP 1000 ml.  Both recalls are linked to particulates.

The sodium chloride recall was triggered by unidentified particulate matter found near the administration port. The two lots of dialysis solution were recalled after oxidized stainless steel, garment fiber and polyvinyl chloride particulates were identified during the manufacturing process.

Baxter did not elaborate on the specific cause of the particulates or what it did to resolve the issues.

The drugmaker has not received any adverse events related to the recalled products, but health risks — such as blocked blood vessels — are of concern with administration of a product containing particulates.

With the dialysis solution, particulate matter could create a focal point for infection if any pre-existing peritonitis exists, possibly resulting in death, Baxter said.

The recalls come one month after Baxter pulled four lots of intravenous solution off the shelves due to complaints of plastic and fiber particles.

The recall of 0.9 percent sodium chloride injection comes in the midst of an ongoing saline shortage first reported in January. In April, Baxter agreed to temporarily distribute saline in the U.S. from its Spain manufacturing facility to help boost supplies, according to the FDA.

Baxter did not return a request for comment by press time.

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