FDA recall D-0325-2024

IntegraDose Compounding Services LLC · Class II · drug

Product

Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride Sterile Syringe for Injection, Concentration: 1 Unit/mL, 2 mL Syringe, Rx Only, 719 Kasota Ave SE, Minneapolis, MN, Compounded Drug Not for Resale. Office Use Only, NDC 71139-0190-1.

Reason for recall

Sub-potent drug: failure to maintain potency through the duration of the labeled expiration/beyond-use date.

Distribution

MN

Key facts

Status
Ongoing
Initiation date
2024-01-22
Report date
2024-02-21
Voluntary/Mandated
Voluntary: Firm initiated
Location
Minneapolis, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0325-2024