Reported Oct 5, 2022 · Terminated

oxyTOCIN 30 Units/500 mL (0.06 Units/mL) added to 0.9% Sodium Chloride, Injection for IV Use, High Alert, This is a…

QuVa Pharma, Inc.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: QuVa Pharma, Inc. · 519 State Route 173 · Bloomsbury, NJ · 08804-4047

Is this the product you have?

  • 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 volume500 mL bag
  • NDC70092-1068-07
Lot codes and dates
    • Lot 30027403
    • BUD 11/14/2022
Amount recalled
1994 bags

Where it was sold

  • Nationwide

Why it was recalled

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).

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Feb 8, 2023 · Data as of Sep 19, 7:21 PM UTC

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