Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Lack of sterility assurance.
Oxytocin 30 units in NS 500 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
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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