ISSUE: American Regent, Inc. is conducting a nationwide voluntary recall of multiple lots of Vasopressin Injection, USP to the Retail/Hospital level. This product recall 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. See the company Press Release for a listing of affected lot numbers. The products were distributed to wholesalers and distributors nationwide.
BACKGROUND: 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.
RECOMMENDATION: Hospitals, infusion centers, clinics, retail pharmacies and other healthcare facilities should not use American Regent, Inc., Vasopressin Injection, USP Multiple Dose Vials with the lot #s listed for patient care and should immediately quarantine any product for return to American Regent Inc.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[08/02/2011 - Press Release - American Regent, Inc]