FDAFDA · Food and drugs·Recall number D-0499-2019
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.
Published February 27, 2019 · Recall initiated: February 6, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Advanced Pharma Inc.
- Distributor
- Nationwide in the USA.
- Lot
- 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
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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