Drug product
Oxytocin 30 Units/500 mL (0.06 Units/mL) in 0.9% Sodium Chloride Injection, USP, 500 mL Single-Dose Container Bag, 10 x 1 IV Bag, Rx Only Nephron 503B outsourcing facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-543-50
D-0964-2022
Product summary
- Event
- Event 90211
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3587 bags
- Official record key
drug-enforcement:D-0964-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lots: OX2008C, Exp. 5/27/2022; OX2010C, Exp. 6/17/2022; OX2011C, OX2011D, Exp. 6/24/2022
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility