Par Sterile Products LLC initiated a Class II recall of Vasostrict (vasopressin in 5% Dextrose) Injection on January 11, 2024. The recall is documented under FDA event ID D-0232-2024.
The affected product is Vasostrict, 20 units per 100 mL (0.2 units per mL), supplied as 100 mL Single Dose Vials, 10 per carton, for intravenous infusion. It is distributed by Par Pharmaceutical, Chestnut Ridge, NY, under NDC 42023-237-10.
The stated reason for the recall is that the product was found to be superpotent. Assay results from the 3-month and 6-month stability intervals exceeded the upper specification limit.
FDA has classified this action as a Class II recall. The recall status is listed as ongoing.
This recall action pertains specifically to the identified lot and stability testing results as described in the FDA record. It does not by itself indicate that vasopressin as a therapy is unsafe. Readers seeking general background on this compound can consult the compound overview for additional context.