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 II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Subpotent drug - Product did not contain drug.
Cause type: Wrong potency / content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.
What was recalled
oxyTOCIN 30 Units/500 mL (0.06 Units/mL) added to 0.9% Sodium Chloride Injection for IV Use, Rx only, QuVa Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 888-339-0874, NDC 70092-1068-07
Affected NDC
70092-1068-07
Compare with the code on your package — it is the most precise check available.
Drug: Oxytocin
- Recalling firm
- QuVa Pharma, Inc.
- NDC code
- 70092-1068-07
- Origin
- TX, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1302-2020 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. 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 2020 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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