FDAFDA · Alimentos y medicamentos·N.º oficial D-1655-2012

Daytrana (methylphenidate) transdermal system patch, Delivers 15 mg over 9 hours (1.6 mg/hr), 1 patch per pouch, packaged in 30-count patches per box, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC 68968-5553-3.

Name: Daytrana (methylphenidate) transdermal system patch, Delivers 15 mg over 9 hours (1.6 mg/hr), 1 patch per pouch, packaged in 30-count patches per box, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC 68968-5553-3.
Brand: DAYTRANA

Publicado el 29 de agosto de 2012 · Inicio del retiro: 12 de julio de 2012

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

Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to the patient's ability to remove the release liner from the patch adhesive prior to administration.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Marca: DAYTRANA
Fabricante: Noven Pharmaceuticals, Inc.
Distribuidor: Nationwide and Puerto Rico.
Lote: Lot #53823, Exp 08/12
Clasificación de riesgo: Class II
Área (FDA): drug
País: United States