American Regent, Inc. Initiates Voluntary Recall of Seventeen Lots of Vasopressin Injection, USP, Multiple Dose Vials due to Sub-Potency
SHIRLEY, N.Y., Aug. 3, 2011 /PRNewswire/ -- American Regent, Inc. is conducting a nationwide voluntary recall of 5 lots of Vasopressin Injection, USP 20 units/mL (200 units/10 mL), 10 mL Multiple Dose Vials; 11 lots of Vasopressin Injection, USP 20 units/mL, 1 mL Multiple Dose Vials; and 1 lot of Vasopressin Injection, USP 10 units/0.5 mL, 0.5 mL Multiple Dose Vials to the Retail/Hospital level. Recall of this product was initiated by American Regent, Inc. because some vials may not maintain potency throughout their shelf-life.
Potential adverse events after administration of solutions that are below potency limits may include reduced effectiveness. American Regent, Inc. has received no reports of adverse events related to reduced effectiveness for Vasopressin Injection, USP of the lots being recalled during the time period January 1, 2009 to July 27, 2011.
Vasopressin Injection, USP is indicated for prevention and treatment of postoperative abdominal distention, in abdominal roentgenography to dispel interfering gas shadows, and in diabetes insipidus.
Below are the product sizes and lots affected. The product was distributed to wholesalers and distributors nationwide.Vasopressin Injection, USP 20 units/mL (200 units/10 mL), 10 mL multiple dose vial,Package Size: 10, NDC # 0517-0410-10Lot #Exp DateExp Period9677
18 monthsVasopressin Injection, USP 20 units/mL, 1 mL multi