FDAFDA · Alimentos y medicamentos·N.º oficial D-0218-2025

Granix (tbo-filgrastim) Injection 300 mcg/0.5 mL, Single Dose prefilled syringe, packaged as a) 1 syringe in 1 CARTON, NDC 63459-910-11, Blister NDC 63459-910-12; (b)10 syringes in 1 CARTON, NDC 63459-910-15, Blister NDC 63459-910-12; (c) 1 syringe in 1 CARTON, NDC 63459-910-17 without safety guard and blister, Rx Only, Manufactured by: UAB Teva Baltics, Vilnius, Lithuania. Distributed by Teva Pharmaceuticals USA, Inc. North Wales PA 19454. Product of Israel.

Name: Granix (tbo-filgrastim) Injection 300 mcg/0.5 mL, Single Dose prefilled syringe, packaged as a) 1 syringe in 1 CARTON, NDC 63459-910-11, Blister NDC 63459-910-12; (b)10 syringes in 1 CARTON, NDC 63459-910-15, Blister NDC 63459-910-12; (c) 1 syringe in 1 CARTON, NDC 63459-910-17 without safety guard and blister, Rx Only, Manufactured by: UAB Teva Baltics, Vilnius, Lithuania. Distributed by Teva Pharmaceuticals USA, Inc. North Wales PA 19454. Product of Israel.
Brand: GRANIX

Publicado el 12 de febrero de 2025 · Inicio del retiro: 10 de enero de 2025

Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

Failed Stability Specifications - 12-month stability test result for one of the known peptides is below the specification limit

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Marca: GRANIX
Fabricante: Teva Pharmaceuticals USA, Inc
Distribuidor: Product was distributed nationwide.
Lote: Lot # (a) 135738, (b) 137149, (c) 137148, Exp. date 09/30/2025
Clasificación de riesgo: Class II
Área (FDA): drug
País: United States

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