Drug product
oxyTOCIN 30 Units/500 mL (0.06 Units/mL) added to 0.9% Sodium Chloride, Injection for IV Use, High Alert, This is a Compounded Product for Institutional or Office Use Only, Not for Resale, QuVa PHARMA 519 Route 173, Bloomsbury, NJ 08804, Total volume: 500 mL bag, NDC: 70092-1068-07.
D-1544-2022
Product summary
- Event
- Event 90898
- Status
- Terminated
- Classification
- Class III
- Quantity
- 1994 bags
- Official record key
drug-enforcement:D-1544-2022
Official wording
Reason: Incorrect Product Formulation: Oxytocin 30 units was added to an IV bag of 0.45% Sodium Chloride (500mL) instead of 0.9% Sodium Chloride (500mL).
Code information: Lot 30027403, BUD 11/14/2022
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Unknown
Incorrect Product Formulation: Oxytocin 30 units was added to an IV bag of 0.45% Sodium Chloride (500mL) instead of 0.9% Sodium Chloride (500mL).