Par Sterile Products LLC: Drug Recall

Recall #D-0232-2024 · 01/11/2024

Class II: Risk

Recall Details

Recall Number: D-0232-2024
Classification: Class II
Product Type: Drug
Recalling Firm: Par Sterile Products LLC
Status: Ongoing
Date Initiated: 01/11/2024
Location: Rochester, MI, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1721 cartons

Reason for Recall

Superpotent Drug: Assay from the 3-month and 6-month stability intervals exceeded the upper specification limit.

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

Distribution Pattern

Nationwide USA

Other Recalls by Par Sterile Products LLC

Class I: Dangerous 03/04/2024

Presence of Particulate Matter.
Class II: Risk 11/09/2021

Crystallization: presence of white, crystalline product agglomeration observed in 2 vials during annual inspection of retain samples.

View all recalls by Par Sterile Products LLC →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.