FDAFDA · Alimentos y medicamentos·N.º oficial D-001-2014

Copaxone (glatiramer acetate injection), 20 mg/1 mL, 1 mL pre-filled syringe, packaged in 30 single-use PRE-FILLED Syringes and 33 Alcohol Preps (Swabs) per carton, Rx only, Marketed by: Teva Neuroscience, Inc., Kansas City, MO 64131; Distributed by: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 68546-317-30, UPC 3 68546 31730 4.

Name: Copaxone (glatiramer acetate injection), 20 mg/1 mL, 1 mL pre-filled syringe, packaged in 30 single-use PRE-FILLED Syringes and 33 Alcohol Preps (Swabs) per carton, Rx only, Marketed by: Teva Neuroscience, Inc., Kansas City, MO 64131; Distributed by: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 68546-317-30, UPC 3 68546 31730 4.
Brand: COPAXONE

Publicado el 27 de noviembre de 2013 · Inicio del retiro: 24 de octubre de 2013

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

Presence of Particulate Matter: A foreign particle found in a pre-filled syringe was reported through a consumer complaint about a pre-filled syringe.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Marca: COPAXONE
Fabricante: Teva Pharmaceuticals USA
Distribuidor: Nationwide
UPC: 368546317304
Lote: Lot X06381, Exp 10/14
Clasificación de riesgo: Class II
Área (FDA): drug
País: United States