Baxter Initiates Voluntary Recall of All Unexpired Lots of 50mm 0.2 Micron Filters- Drug Information Update

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The FDA is alerting compounding facilities that Baxter is voluntarily recalling all unexpired lots of 50mm 0.2 micron filters due to the potential for a missing filter support membrane and for potential presence of particulate matter.

The 50mm 0.2 micron filter is a bacteria and particulate filter for aqueous solutions used during the compounding of solutions. In the absence of the filter support membrane, bacteria and/or particulate matter present in an unsterile solution could pass through to the compounded prepared solution. If not further filtered before patient administration, this could lead to adverse health consequences.

For further information on the recall, see the company’s recall announcement on FDA’s website.

Visit the FDA website for information on compounding.