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.

FDA recall notice · announced February 27, 2019 · Advanced Pharma

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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.

Reason for recall

Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label.

Notes

Distribution: Nationwide in the USA.
Lot/code information: Lots: 12/14/18 1482 70399P, BUD: 02/27/19; 12/14/18 1610 70399P, BUD: 02/27/19
Quantity: 672 bags
Status: Terminated
Products in this recall event:
- 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 (D-0499-2019)
- 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 770 (D-0497-2019)
- 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 770 (D-0498-2019)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.