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 20 Units added to NS 1000 mL
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label.
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 20 Units added to NS 1000 mL (oxytocin and 0.9% Sodium Chloride) Injectable Solution, Approximately 1002 mL Sterile single use bag, Rx only, Avella of Houston, 9265 Kirby Dr., Houston, TX 77054, NDC 42852-703-99.
Affected NDC
42852-0703-99
Compare with the code on your package — it is the most precise check available.
Drug: Oxytocin
- Recalling firm
- Advanced Pharma Inc.
- NDC code
- 42852-703-99
- Origin
- TX, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0498-2019 · 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 Advanced Pharma Inc.
All 2019 recalls
Class II · Moderate risk
HYDROmorphone 20 mg/100 mL Injectable Solution
Sub-potency
Class II · Moderate risk
Phenylephrine HCl
Lack of Assurance of Sterility
Class II · Moderate risk
Morphine Sulfate 30 mg/30 mL
Lack of Assurance of Sterility
Class II · Moderate risk
Phenylephrine HCl
Lack of Assurance of Sterility
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