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FDA Medwatch Alert: Vasopressin Injection USP, Multiple Dose Vials: Recall - Sub-Potency

Posted 4 Aug 2011 by Drugs.com

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, ... Read more

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Asystole, Gastrointestinal Hemorrhage, Esophageal Varices with Bleeding, Diabetes Insipidus, Ventricular Tachycardia, Abdominal Distension Prior to Abdominal X-ray, Postoperative Gas Pains, Ventricular Fibrillation

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