FDA recall D-0232-2024

Product

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.

Distribution

Nationwide USA

Key facts

Status

Ongoing

Initiation date

2024-01-11

Report date

2024-01-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Rochester, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0232-2024