Drug product
Oxytocin 30 Units added to NS 500 mL (oxytocin and 0.9% Sodium Chloride) Injectable Solution, Approximately 503 mL Sterile single use bag, Rx only, Avella of Houston, 9265 Kirby Dr., Houston, TX 77054, NDC 42852-706-50.
D-0499-2019
Product summary
- Event
- Event 82089
- Status
- Terminated
- Classification
- Class III
- Quantity
- 1460 bottles
- Official record key
drug-enforcement:D-0499-2019
Official wording
Reason: Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label.
Code information: Lots: 11/27/18 3177 70650P, BUD: 02/10/2019; 11/27/18 6618 70650P, BUD: 02/10/2019; 11/28/18 7716 70650P, BUD: 02/12/19; 12/31/18 5698 70650P, BUD: 03/16/19
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Potency or specification failure
Superpotent