FDAFDA · Alimentos y medicamentos·N.º oficial D-0155-2015
Tri-mix ST1, 30 mg/1.5 mg/50 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
Publicado el 5 de noviembre de 2014 · Inicio del retiro: 27 de agosto 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 Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.
Qué hacer
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Detalles del retiro
- Fabricante
- Martin Avenue Pharmacy, Inc.
- Distribuidor
- Nationwide
- Lote
- Lot Number 06102014@38, Exp 9/8/2014; 06122014@9, Exp 9/10/2014; 07152014@59, Exp 9/30/2014; 07302014@23, Exp 10/28/2014
- Clasificación de riesgo
- Class II
- Área (FDA)
- drug
- País
- United States