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Voluntary recall issued on Vasopressin injections

American Regent, Inc. is conducting a nationwide voluntary recall of five lots of Vasopressin Injection, USP 20 units/mL (200 units/10mL), 10 mL Multiple Dose Vials; 11 lots of Vasopressin Injection, USP 20 units/mL, 1 mL Multiple Dose Vials; and one 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. last week 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 Jan. 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 # 0517-0410-10• Lot: 9677 Expires: October 2011 Exp period: 24 Months• Lot: 0052 Expires: January 2012 Exp period: 24 Months• Lot: 0294 Expires: October 2011 Exp period: 18 Months• Lot: 0442 Expires: December 2011 Exp period: 18 Months• Lot: 0663 Expires: April 2012 Exp period: 18 MonthsVasopressin Injection, USP 20 units/mL, 1 mL multiple dose vial, Package Size: 25, NDC # 0517-1020-25• Lot: 9532 Expires: August 2011 Exp period: 24 Months• Lot: 9618 Expires: September 2011 Exp period: 24 Months• Lot: 9707 Expires: October 2011 Exp period: 24 months• Lot: 0104 Expires: February 2012 Exp period: 24 months• Lot: 0124 Expires: February 2012 Exp period: 24 months• Lot: 0273 Expires: October 2011 Exp period: 18 months• Lot: 0346 Expires: November 2011 Exp period: 18 months• Lot: 0400 Expires: December 2011 Exp period: 18 months• Lot: 0437 Expires: December 2011 Exp period: 18 months• Lot: 0618 Expires: March 2012 Exp period: 18 months• Lot: 0758 Expires: May 2012 Exp period: 18 monthsVasopressin Injection, USP 10 units/0.5 mL, 0.5 mL multiple dose vial, Package Size: 25, NDC # 0517-0510-25• Lot: 0103 Expires: February 2012 Exp period: 24 MonthsHospitals, infusion centers, clinics, retail pharmacies and other healthcare facilities should not use American Regent, Inc., Vasopressin Injection, USP Multiple Dose Vials with the lot numbers listed above for patient care and should immediately quarantine any product for return to American Regent Inc.American Regent, Inc. will credit accounts for all returned product with these lot numbers.Those with questions about the return or recall process, please call our Customer Service Department at 1-877-788-3232: Monday through Friday from 8:30 a.m. to 7 p.m., EDT.Hospitals, infusion centers, clinics, retail pharmacies and other healthcare facilities with product quality complaints, medical or other questions concerning the use of the product or reasons for this recall should contact the Professional Services Department at 1-877-788-3232: Monday through Friday from 9 a.m. to 5 p.m., EDT.Any adverse reactions experienced with the use of this product should be reported to American Regent, Inc. via e-mail at

pv@luitpold.com, by fax to (610) 650-0170, or by phone at 1-800-734-9236: Monday through Friday from 9 a.m. to 5 p.m., EDT.To expediate handling, please do not report anything other than adverse events to this email address, fax, or phone.Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program online at

www.fda.gov/medwatch/report.htm1.This voluntary recall is being conducted with the knowledge of the U.S. Food & Drug Administration.