OxyTOCIN IV Solution (QuVa Pharma) – Incorrect Formulation (2022)
Class III: A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences
Class III recall indicates unlikely adverse health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
QuVa Pharma, Inc.
Lot Codes / Batch Numbers
Lot 30027403, BUD 11/14/2022
Products Sold
Lot 30027403, BUD 11/14/2022
QuVa Pharma, Inc. is recalling oxyTOCIN 30 Units/500 mL (0.06 Units/mL) added to 0.9% Sodium Chloride, Injection for IV Use, High A due to 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 is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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).
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026