FDAFDA · Alimentos y medicamentos·N.º oficial F-1026-2017
Prostamax Dietary Supplement (unknown container size)
Publicado el 4 de enero de 2017 · Inicio del retiro: 13 de octubre 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
Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operations.
Qué hacer
FDA Mandated · Letter
Detalles del retiro
- Fabricante
- Sunset Natural Products Inc.
- Distribuidor
- Products distributed to Florida, Nevada and the Dominican Republic
- Lote
- As persuant to the Consent Decree, the firm agreed to "recall and destroy, under FDA's supervision, in accordance with the procedures provided in paragraph 6, ALL dietary supplements that were manufactured, prepared, processed, packed, labeled, held and/or distributed between April 2, 2014 and the date of entry of this Decree." The Decree was entered on September 25, 2015. Known lot: Lot # 410414, 490414, 270514, 590714, 140215, 310215, 080415, 270515, 150815
- Clasificación de riesgo
- Class II
- Área (FDA)
- food
- País
- United States
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