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FDAFDA · Alimentos y medicamentos·N.º oficial D-1149-2016

XCEL Capsules, 300 mg, 60-count bottles, Manufactured for JNS Health

Publicado el 13 de julio de 2016 · Inicio del retiro: 15 de diciembre de 2015

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

Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared fluoxetine, an FDA approved drug used to treat depression, anxiety, panic attacks, obsessive-compulsive disorder, or bulimia and phenolphthalein, an ingredient found in over-the-counter laxative products that was withdrawn from the US market due to concerns of carcinogenicity, making it an unapproved drug.

Qué hacer

Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Detalles del retiro

Fabricante
Bee Extremely Amazed LLC
Distribuidor
Nationwide
Lote
All lots
Clasificación de riesgo
Class I
Área (FDA)
drug
País
United States