Perfil del fabricante
Advanced Rx of Tennessee, LLC
Compañía farmacéutica5 productos registrados
5
productos registrados
604.577
notificaciones totales
85
retiradas registradas
51,2%
graves en total
Productos
mostrando 5 de 5
| Producto | Aprobado | Notificaciones ↓ | Señal principal | Retiradas |
|---|---|---|---|---|
| 1981 | 291.471 | Problema con el sistema de administración del dispositivo | 42 | |
| 1995 | 289.568 | Problema con el sistema de administración del dispositivo | 30 | |
| 1981 | 12.337 | Dermatitis atópica | 12 | |
| 2002 | 6966 | Producto retirado administrado | 1 | |
| 2007 | 4235 | Erupción en el lugar de aplicación | 0 |
Historial de retiradas · 43 registradas
| Fecha | Clase | Motivo | Empresa |
|---|---|---|---|
| 17 mar 2026 | II | Labelling: Illegible label | Nephron SC, LLC |
| 24 jul 2025 | III | Failed Stability Specifications: Out of specification results was observed in Induction Port during the analysis of Particle size distribution at the 12-month time point. | Cipla USA, Inc. |
| 14 may 2025 | II | Defective delivery system | AsttraZeneca Pharmaceuticals LP |
| 26 mar 2024 | II | Short fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch. | Cipla USA, Inc. |
| 27 jun 2023 | I | Defective container: empty inhaler and leakage observed through the inhaler valve due to partially missing bottom seat (gasket). | Cipla USA, Inc. |
| 26 abr 2023 | II | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. |
| 22 dic 2022 | II | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Pharmacy Innovations |
| 13 abr 2022 | III | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office |
| 13 abr 2022 | II | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office |
| 13 abr 2022 | II | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office |
| 13 abr 2022 | II | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office |
| 13 abr 2022 | II | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office |
| 13 abr 2022 | II | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office |
| 13 abr 2022 | II | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office |
| 13 abr 2022 | II | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office |
| 26 ene 2022 | II | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | CARDINAL HEALTHCARE |
| 26 ene 2022 | II | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | CARDINAL HEALTHCARE |
| 26 ene 2022 | II | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | CARDINAL HEALTHCARE |
| 15 mar 2021 | II | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. |
| 15 mar 2021 | II | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. |
| 16 sept 2020 | II | Defective Delivery System: Sustained trend of failure to dispense complaints. | Perrigo Company PLC |
| 12 nov 2019 | II | Lack of Processing Controls | Integrated Health Concepts Inc. dba Conversio Health |
| 12 nov 2019 | II | Lack of Processing Controls | Integrated Health Concepts Inc. dba Conversio Health |
| 12 nov 2019 | II | Lack of Processing Controls | Integrated Health Concepts Inc. dba Conversio Health |
| 12 nov 2019 | II | Lack of Processing Controls | Integrated Health Concepts Inc. dba Conversio Health |
| 12 nov 2019 | II | Lack of Processing Controls | Integrated Health Concepts Inc. dba Conversio Health |
| 12 nov 2019 | II | Lack of Processing Controls | Integrated Health Concepts Inc. dba Conversio Health |
| 12 nov 2019 | II | Lack of Processing Controls | Integrated Health Concepts Inc. dba Conversio Health |
| 12 nov 2019 | II | Lack of Processing Controls | Integrated Health Concepts Inc. dba Conversio Health |
| 3 abr 2018 | II | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. |
| 25 jul 2017 | III | Failed Impurities/Degradation Specifications: high out of specification results for related compound D. | Teva Pharmaceuticals USA |
| 16 may 2017 | II | Defective Delivery System: Elevated number of units with out of specification results for leak rate | GlaxoSmithKline, LLC |
| 22 mar 2017 | II | Defective Delivery System: Elevated number of units with out of specification results for leak rate. | GlaxoSmithKline, LLC |
| 12 ene 2017 | III | Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant. | Actavis Inc |
| 22 jun 2016 | II | Presence of Foreign Substance; presence of black particles describes generically as cellulose-based bundles of brown fibrous material. | Teva North America |
| 3 dic 2015 | II | Defective Delivery System: Some canisters may not contain sufficient propellant to deliver the labeled claim of 200 actuations through the end of shelf life. | GlaxoSmithKline, LLC |
| 21 ago 2015 | II | Lack of Assurance of Sterility; potential exposure to non-sterile lubricant during the filling process | Nephron Pharmaceuticals Corp. |
| 24 jul 2015 | II | Defective Delivery System: Inhalers do not spray properly, emitting either no spray or a short transient spray. | Boehringer Ingelheim Roxane Inc |
| 14 nov 2014 | II | Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin. | Attix Pharmaceuticals |
| 2 oct 2013 | II | Lack of Assurance of Sterility: Nephron Pharmaceuticals Corporation conducted a routine periodic aseptic process simulation and discovered bacterial growth in a number of media fill vials, exceeding the allowable limit. | Nephron Pharmaceuticals Corp. |
| 2 jul 2013 | II | Labeling: Label Mixup: ALBUTEROL SULFATE ER, Tablet, 4 mg may have potentially been mislabeled as one of the following drugs: SIMVASTATIN, Tablet, 20 mg, NDC 16714068303, Pedigree: W003580, EXP: 6/24/2014. | Aidapak Services, LLC |
| 26 jul 2012 | II | Does Not Deliver Proper Metered Dose: Potential content of albuterol per dose is below specification. | GlaxoSmithKline Inc |
| 22 jun 2011 | II | Lack of Assurance of Sterility | Nephron Pharmaceuticals Corp. |
Clase I = probabilidad razonable de daño grave · Clase II = temporal o reversible · Clase III = improbable que cause daño.
Estado de registro
Algunos productos de Advanced Rx of Tennessee, LLC no están registrados por la FDA para uso humano. Para las sustancias no registradas (péptidos, SARM sin registro humano) no existe ningún proveedor legítimo para uso humano. La ausencia de una vía de aprovisionamiento es la información de seguridad.