Baxter Recalls Micron Filters

October 3, 2016

The company is voluntarily recalling all unexpired lots of 50-mm, 0.2-micron filters.

Baxter announced on Sept. 27, 2016 that it was voluntarily recalling all unexpired lots of 50-mm, 0.2-micron filters because of the potential for a missing filter support membrane and the potential presence of particulate matter. The component was manufactured by an external supplier, and the problems were identified by compounding pharmacies before the product reached patients.

The recalled filters, which filter bacteria and particulates, are used for aqueous solutions during compounding. According to Baxter, “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.”

The recalled lots were distributed between August 22, 2013 and June 20, 2016. The recalled product code is H93835, with an expiration date of June 27, 2016–June 27, 2019.

Source: FDA