Perfil del fabricante
Advagen Pharma Ltd.
Compañía farmacéutica3 productos registrados
3
productos registrados
255.687
notificaciones totales
128
retiradas registradas
56,5%
graves en total
Productos
mostrando 3 de 3
| Producto | Aprobado | Notificaciones ↓ | Señal principal | Retiradas |
|---|---|---|---|---|
| 1990 | 189.078 | Asma | 19 | |
| — | 37.381 | Asma | 100 | |
| — | 29.228 | Asma | 9 |
Historial de retiradas · 50 registradas
| Fecha | Clase | Motivo | Empresa |
|---|---|---|---|
| 8 abr 2026 | II | Defective container: defect in a batch of bottle caps, specifically involving dislodged or missing cap liners. | Apotex Corp. |
| 12 dic 2025 | I | Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter. | Medinatura New Mexico, inc. |
| 12 dic 2025 | I | Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter. | Medinatura New Mexico, inc. |
| 14 feb 2024 | II | CGMP Deviations:Suspected potential presence of Burkholderia cepacia complex | Golden State Medical Supply Inc. |
| 9 feb 2024 | II | CGMP Deviations: potential presence of Burkholderia cepacia complex | Apotex Corp. |
| 28 dic 2023 | II | CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products. | Seaway Pharma Inc. |
| 28 dic 2023 | II | CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products. | Seaway Pharma Inc. |
| 26 abr 2023 | II | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. |
| 23 feb 2023 | II | CGMP Deviations: Raw material recalled by repackager, due to discoloration. | Nutraceutical Corporation |
| 23 feb 2023 | II | CGMP Deviations: Raw material recalled by repackager, due to discoloration. | Nutraceutical Corporation |
| 13 jun 2022 | II | Defective container: defect prevents product from dispensing as intended. | Akorn, Inc. |
| 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 |
| 24 ene 2022 | II | cGMP deviations | Ultra Seal Corporation |
| 26 oct 2021 | II | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. | Perrigo Company PLC |
| 26 oct 2021 | II | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. | Perrigo Company PLC |
| 26 oct 2021 | II | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. | Perrigo Company PLC |
| 26 oct 2021 | II | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. | Perrigo Company PLC |
| 26 oct 2021 | II | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. | Perrigo Company PLC |
| 26 oct 2021 | II | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. | Perrigo Company PLC |
| 26 oct 2021 | II | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. | Perrigo Company PLC |
| 22 sept 2021 | II | Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol | Teva Pharmaceuticals USA |
| 22 sept 2021 | II | Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol | Teva Pharmaceuticals USA |
| 22 sept 2021 | II | Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol | Teva Pharmaceuticals USA |
| 22 sept 2021 | II | Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol | Teva Pharmaceuticals USA |
| 22 sept 2021 | II | Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol | Teva Pharmaceuticals USA |
| 15 mar 2021 | II | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. |
| 21 may 2019 | II | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). | Torrent Pharma Inc |
| 21 may 2019 | II | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). | Torrent Pharma Inc |
| 3 ago 2018 | II | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC |
| 3 ago 2018 | II | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC |
| 3 ago 2018 | II | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC |
| 3 ago 2018 | II | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC |
| 3 ago 2018 | II | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC |
| 3 ago 2018 | I | Microbial Contamination of Non-Sterile Products: Failed microbiological testing for Pseudomonas aeruginosa. | Product Quest Manufacturing LLC |
| 31 may 2018 | II | Presence of foreign substance: glass particles | Apotex Inc. |
| 9 feb 2018 | II | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. | American Pharmaceutical Ingredients LLC |
| 5 jul 2016 | II | Marketed Without An Approved NDA/ANDA: product is an unapproved drug due to nasal decongestant claims as well as not complying with the nasal decongestant final monograph. | Let's Talk Health, Inc. |
| 27 feb 2015 | II | Failed Stability Specifications: Out of specification for preservative, benazalkonium chloride. | Akorn, 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 |
| 30 ene 2013 | II | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | TG United, Inc. |
| 30 ene 2013 | II | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | TG United, Inc. |
| 30 ene 2013 | II | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | TG United, Inc. |
| 30 ene 2013 | II | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | TG United, Inc. |
| 30 ene 2013 | II | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | TG United, Inc. |
| 30 ene 2013 | II | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | TG United, Inc. |
| 30 ene 2013 | II | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | TG United, Inc. |
| 30 ene 2013 | II | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | TG United, Inc. |
| 18 dic 2012 | I | Microbial Contamination of Non-Sterile Products: Product may be contaminated with Burkholderia cepacia. | Matrixx Initiatives Inc |
Clase I = probabilidad razonable de daño grave · Clase II = temporal o reversible · Clase III = improbable que cause daño.
Estado de registro
Algunos productos de Advagen Pharma Ltd. 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.