Class I · High risk
Oxytocin 30 Units/500 mL in 0.9% Sodium Chloride for intravenous use
Subpotent Drug: Testing revealed there was no oxytocin in the IV bag.
oxyTOCIN 30 Units/500 mL
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
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).
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
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.
Affected NDC
70092-1068-07
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Drug: Oxytocin
- Recalling firm
- QuVa Pharma, Inc.
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1544-2022 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Oxytocin recalls
See all
Class II · Moderate risk
Oxytocin for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Oxytocin 0.9% Sodium Chloride Injection USP
cGMP violations
Class III · Low risk
Oxytocin synthetic
Labeling: Not Elsewhere Classified
Class II · Moderate risk
oxyTOCIN
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Other recalls by QuVa Pharma, Inc.
All 2022 recalls
Class II · Moderate risk
Methohexital Sodium
Failed Impurities/Degradation Specifications
Class II · Moderate risk
R.E.C.K.
Presence of Particulate Matter
Class II · Moderate risk
fentaNYL Citrate PF 200 mcg/100 mL
Lack of Assurance of Sterility
Class II · Moderate risk
fentaNYL Citrate PF 200 mcg/100 mL
Lack of Assurance of Sterility
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