QuVa Pharma, Inc.: Drug Recall

Recall #D-1544-2022 · 09/20/2022

Class III: Low Risk

Recall Details

Recall Number
D-1544-2022
Classification
Class III
Product Type
Drug
Recalling Firm
QuVa Pharma, Inc.
Status
Terminated
Date Initiated
09/20/2022
Location
Bloomsbury, NJ, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1994 bags

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).

Product Description

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.

Distribution Pattern

Nationwide in the USA

Other Recalls by QuVa Pharma, Inc.

View all recalls by QuVa Pharma, Inc. →

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.