Drug product
Oxytocin 20 Units added to NS 1000 mL (oxytocin and 0.9% Sodium Chloride) Injectable Solution, Approximately 1002 mL Sterile single use bag, Rx only, Avella of Houston, 9265 Kirby Dr., Houston, TX 77054, NDC 42852-703-99.
D-0498-2019
Product summary
- Event
- Event 82089
- Status
- Terminated
- Classification
- Class III
- Quantity
- 672 bags
- Official record key
drug-enforcement:D-0498-2019
Official wording
Reason: Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label.
Code information: Lots: 12/14/18 1482 70399P, BUD: 02/27/19; 12/14/18 1610 70399P, BUD: 02/27/19
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Potency or specification failure
Superpotent