Drug product
Oxytocin 10 Units added to NS 1000 mL (oxytocin and 0.9% Sodium Chloride) Injectable Solution, Approximately 1001 mL Sterile single use bag, Rx only, Avella of Houston, 9265 Kirby Dr., Houston, TX 77054, NDC 42852-730-99.
D-0497-2019
Product summary
- Event
- Event 82089
- Status
- Terminated
- Classification
- Class III
- Quantity
- 12 bags
- Official record key
drug-enforcement:D-0497-2019
Official wording
Reason: Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label.
Code information: Lot: 12/20/18 1056 73099P, BUD: 02/03/2019
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Potency or specification failure
Superpotent