Vasostrict (vasopressin in 5% Dextrose) Injection, 20 units per 100 mL (0.2 units per mL), 100 mL...
FDA Recall #D-0232-2024 — Class II — January 11, 2024
Product Description
Vasostrict (vasopressin in 5% Dextrose) Injection, 20 units per 100 mL (0.2 units per mL), 100 mL x 10 Single Dose Vials per carton, Ready to Use, For Intravenous Infusion, Rx Only, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977. NDC: 42023-237-10
Reason for Recall
Superpotent Drug: Assay from the 3-month and 6-month stability intervals exceeded the upper specification limit.
Recalling Firm
Par Sterile Products LLC — Rochester, MI
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
1721 cartons
Distribution
Nationwide USA
Code Information
Lot # 66702; Exp. 02/2025
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated