Baxter International Inc., is recalling all unexpired lots of 50mm 0.2 micron filters used to filter bacteria and particulate matter in compounded solutions, such as those manufactured by compounding pharmacies. The recall was initiated because of issues with a component of the filter made by an external supplier, and was identified as a result of complaints from compounding facilities.
Without the filter support membrane, the bacteria and/or particulate matter present in an unsterile solution could pass through to the compounded prepared solution. If not filtered again before the product is administered to a patient, this defect could cause adverse health consequences.
The recall involves all unexpired lots of the 50mm 0.2 micron filters with product code H93835 and expiration dates 6/27/2016 – 6/27/2019. Affected products were distributed to customers and distributors globally between Aug. 22, 2013, and June 20, 2016. Baxter is directing customers not to use the devices from the recalled lots and to return them to the company for credit.
Any adverse events or quality issues regarding this recall should be reported to the Food and Drug Administration (FDA) MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.