UPDATED 10/06/2016. Class I Recall notice issued by FDA.
AUDIENCE: Risk Manager, Pharmacy
ISSUE: Baxter International Inc. announced today it is voluntarily recalling all unexpired lots of 50mm 0.2 micron filters (product code H93835, expiration 6/27/2016 – 6/27/2019) due to the potential for a missing filter support membrane and for potential presence of particulate matter. These issues are associated with a component manufactured by an external supplier, and were identified prior to patient involvement as a result of complaints from customers at compounding facilities.
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.
BACKGROUND: The 50mm 0.2 micron filter is a bacteria and particulate filter for aqueous solutions used during the compounding of solutions.
RECOMMENDATION: The lots being recalled were distributed to customers and distributors globally between August 22, 2013 and June 20, 2016. Baxter is directing customers not to use the product from the recalled lots. Recalled product should be returned to Baxter for credit by contacting Baxter Healthcare Center for Service at 1-888-229-0001, Monday through Friday, between the hours of 7 a.m. and 6 p.m., Central Time. Although the product has been discontinued for reasons unrelated to this recall, Baxter will work with customers to direct them toward suitable alternative products, if necessary.
Customers with questions regarding this recall can call Baxter at 1-800-422-9837, Monday through Friday, between the hours of 8 a.m. and 5 p.m. Central Time.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178