American Regent announced that it has resumed shipment of all vial sizes of Venofer (iron sucrose injection). On April 21, 2011, American Regent announced the temporary suspension of the distribution and manufacture of products at its Shirley, NY, facility in response to an FDA inspection due to the presence of particulate matter in a few of its generic injectables. There were no product or quality issues raised by FDA specifically to Venofer, however, American Regent had independent cGMP consultants perform a Product Quality Assessment on Venofer, verifying the integrity of the product. American Regent confirms that Venofer meets all USP and internal quality release specifications for iron sucrose injection and that no changes have been made to the formulation of the product.
All existing open orders for Venofer have been filled and there are more than 1 million vials in inventory. American Regent estimates that it will resume manufacturing of Venofer on May 16, 2011. Future shortages or further disruptions in supply are not expected.
Venofer is indicated for the treatment of iron deficiency anemia in chronic kidney disease.
For more information call (800) 645-1706 or visit www.venofer.com.