Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Lack of Assurance of Sterility
Oxytocin 10 Units added to Lactated Ringers in a 500 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0764-03
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Subpotent Drug: Testing revealed there was no oxytocin in the IV bag.
Reason Lack of Assurance of Sterility
Reason cGMP violations
Reason Labeling: Not Elsewhere Classified
Reason Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
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