Viatrexx is recalling 19 lots of its 10 mL sterile injectable vials of various products because they were manufactured in a way that cannot guarantee sterility.
The products were distributed to about 32 U.S. practitioners and were intended for office use. The recall applies only to the 10 mL vials.
Using a non-sterile product could cause site-specific or systemic infection and could lead to hospitalization, significant morbidity or death, the FDA warned. No adverse events related to this recall have been reported.
Practitioners with the recalled lots should stop using the products and either return them to Viatrexx or discard them.
Read the full news release here.