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 0.9% Sodium Chloride Injection USP
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
cGMP violations
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 0.9% Sodium Chloride Injection USP, 30 units per 500 mL Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-028-59
Affected NDC
71506-0028-59
Compare with the code on your package — it is the most precise check available.
Drug: Oxytocin
- Recalling firm
- Fresenius Kabi Compounding, LLC
- Origin
- MA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0021-2025 · 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 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
Class II · Moderate risk
oxyTOCIN 30 units added to 0.9% sodium chloride 500 mL
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Other recalls by Fresenius Kabi Compounding, LLC
All 2024 recalls
Class II · Moderate risk
vancomycin HCl
Lack of Assurance of Sterility
Class II · Moderate risk
vancomycin HCl
Lack of Assurance of Sterility
Class II · Moderate risk
thiamine HCl
Lack of Assurance of Sterility
Class II · Moderate risk
ketamine HCl
Lack of Assurance of Sterility
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