American Regent recalls Vasopressin Injection, USP

August 12, 2011

American Regent, Inc. is conducting a nationwide voluntary recall of multiple lots of Vasopressin Injection, USP to the retail/hospital level. The company initiated the product recall because some vials may not maintain potency throughout their shelf-life.

American Regent, Inc. is conducting a nationwide voluntary recall of multiple lots of Vasopressin Injection, USP to the retail/hospital level. The company initiated the product recall 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. The products were distributed to wholesalers and distributors nationwide. Visit americanregent.com/NewsEvents for affected lot numbers.

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.

Hospitals, infusion centers, clinics, retail pharmacies, and other healthcare facilities should not use American Regent, Inc.’s Vasopressin Injection, USP multiple dose vials with the lot numbers listed for patient care and should immediately quarantine any product for return to the company.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to FDA’s MedWatch Safety Information and Adverse Event Reporting Program: www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms or call (800) 332-1088 to request a reporting form.