FDAFDA · Alimentos y medicamentos·N.º oficial D-0176-2015
ASCORBIC ACID (with Preservative), 500 mg/mL, injectable, 100 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070.
Publicado el 12 de noviembre de 2014 · Inicio del retiro: 6 de octubre de 2014
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Qué hacer
Voluntary: Firm initiated · Press Release
Detalles del retiro
- Fabricante
- Oregon Compounding Centers, Inc. dba Creative Compounds
- Distribuidor
- Oregon, Washington
- Lote
- Lot #: 20140827@34, discard date: 10/26/2014; Lot #: 20140909@22, discard dae: 11/8/2014; Lot #: 20140912@2, discard date: 11/11/2014.
- Clasificación de riesgo
- Class II
- Área (FDA)
- drug
- País
- United States