Perfil del fabricante
Boiron
Compañía farmacéutica6 productos registrados
6
productos registrados
85.055
notificaciones totales
12
retiradas registradas
81,3%
graves en total
Productos
mostrando 6 de 6
| Producto | Aprobado | Notificaciones ↓ | Señal principal | Retiradas |
|---|---|---|---|---|
| 1946 | 48.897 | Enfermedad renal crónica | 10 | |
| — | 22.469 | Inmunodeficiencia | 0 | |
| 2005 | 8945 | Abuso de drogas | 2 | |
| — | 4170 | problema de sustitución del producto | 0 | |
| — | 572 | Flatulencia vaginal | 0 | |
| — | 2 | — | 0 |
Historial de retiradas · 12 registradas
| Fecha | Clase | Motivo | Empresa |
|---|---|---|---|
| 17 feb 2025 | II | Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes. | Safecor Health, LLC |
| 26 abr 2023 | II | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. |
| 15 mar 2021 | II | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. |
| 31 may 2019 | II | cGMP Deviations: Products may have microbial contamination. | Geritrex, LLC |
| 31 may 2019 | II | cGMP Deviations: Products may have microbial contamination. | Geritrex, LLC |
| 7 may 2018 | II | CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample. | RIJ Pharmaceutical LLC |
| 10 abr 2018 | III | Presence of Foreign Tablets/Capsules | Aidarex Pharmaceuticals LLC |
| 25 mar 2016 | II | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy |
| 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 jul 2013 | II | Labeling: Label Mixup; FERROUS SULFATE, Tablet, 325 mg (65 mg Elemental Iron) may be potentially mislabeled as RAMIPRIL, Capsule, 2.5 mg, NDC 68180058901, Pedigree: AD54549_16, EXP: 5/20/2014. | Aidapak Services, LLC |
| 2 jul 2013 | II | Labeling: Label Mixup; FERROUS SULFATE, Tablet, 325 mg (65 mg Elem Fe) may be potentially mislabeled as COENZYME Q-10, Capsule, 100 mg, NDC 37205055065, Pedigree: W002711, EXP: 6/6/2014; VENLAFAXINE HCL, Tablet, 25 mg, NDC 00093019901, Pedigree: W002825, EXP: 12/31/2013; DOCUSATE SODIUM, Capsule, 250 mg, NDC 00536375710, Pedigree: AD60236_1, EXP: 5/22/2014. | Aidapak Services, LLC |
| 28 dic 2012 | I | Labeling; Label Mixup; bottles of Ferrous Sulfate actually contains Meclizine HCl (indicated for motion sickness) | Advance Pharmaceutical 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 Boiron 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.