Drug product
Oxytocin 30 Units/500 mL (0.06 Units/mL) in 0.9% Sodium Chloride Injection, USP IV bag, packaged in 10 x 1 IV Bag per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-543-50
D-1273-2022
Product summary
- Event
- Event 90512
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1810 bags
- Official record key
drug-enforcement:D-1273-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lots: OX2013C, Exp. 7/9/2022; OX2013E, Exp. 7/9/2022
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility