Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
oxyTOCIN 10 units added to Lactated Ringer's 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 72185-6036-1.
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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