FDAFDA · Alimentos y medicamentos·N.º oficial D-0995-2022
TobraDex (tobramycin and dexamethasone), Ophthalmic Ointment, 3.5 gm, Rx only, Manufacturer: Novartis, NDC 0078-0876-01
Publicado el 15 de junio de 2022 · Inicio del retiro: 13 de abril de 2022
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
cGMP deviations: Temperature abuse
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Marca
- TOBRADEX
- Fabricante
- Mckesson Medical-Surgical Inc. Corporate Office
- Distribuidor
- USA nationwide.
- Lote
- McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer. The letters clearly explain that consignees should identify product received from MMS between June 1 and September 30, 2021. A consignee should be able to use its own records to determine whether it received an impacted product from MMS during that timeframe and whether it still has any of that product in inventory. The recall notification letter informs consignees that they may contact Sedgwick if they have any questions.
- Clasificación de riesgo
- Class II
- Área (FDA)
- drug
- País
- United States
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