FDA recall D-1544-2022

Product

oxyTOCIN 30 Units/500 mL (0.06 Units/mL) added to 0.9% Sodium Chloride, Injection for IV Use, High Alert, This is a Compounded Product for Institutional or Office Use Only, Not for Resale, QuVa PHARMA 519 Route 173, Bloomsbury, NJ 08804, Total volume: 500 mL bag, NDC: 70092-1068-07.

Reason for recall

Incorrect Product Formulation: Oxytocin 30 units was added to an IV bag of 0.45% Sodium Chloride (500mL) instead of 0.9% Sodium Chloride (500mL).

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2022-09-20

Report date

2022-10-05

Termination date

2023-02-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Bloomsbury, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1544-2022