Baxter Recalls Compounding Pharmacy Products
Unexpired lots of micron filters may be missing a filter-support membrane and potentially contain particulate matter.
Baxter has voluntarily recalled all unexpired lots of 50-mm 0.2-micron filters with the product code H93835. These items may be missing a filter-support membrane and potentially contain particulate matter.
The 50-mm 0.2-micron filter is a bacteria and particulate filter designed to be used with aqueous solutions during compounding. The recall affects lots with expiration dates that range from June 27, 2016, to June 27, 2019. Without the filter support membrane, there is the potential for bacteria or particulate matter to enter a prepared solution. Once it is administered to a patient, it can result in adverse health effects. No adverse events have been reported to Baxter as of yet
The issues prompting the recall are associated with a component manufactured by an external supplier that works with Baxter. Compounding facilities identified the errors before the products were distributed.
Baxter has advised its customers to avoid using the product from the recalled lots. Recalled products should be returned to Baxter for credit. The company will work with customers to help them find a suitable alternative product. Customers with questions can contact Baxter at 1-800-422-9837, Monday through Friday, between 8 am and 5 pm Central Time.
Adverse events related to the recalled product should be reported to the FDA’s MedWatch Adverse Event Reporting program online, by regular mail, or fax.