Perfil del fabricante
Clinical Solutions Wholesale, LLC
Compañía farmacéutica2 productos registrados
2
productos registrados
125.251
notificaciones totales
30
retiradas registradas
51,6%
graves en total
Productos
mostrando 2 de 2
| Producto | Aprobado | Notificaciones ↓ | Señal principal | Retiradas |
|---|---|---|---|---|
| 1996 | 123.005 | Analgesia inadecuada | 30 | |
| — | 2246 | Solubilidad anómala del producto | 0 |
Historial de retiradas · 30 registradas
| Fecha | Clase | Motivo | Empresa |
|---|---|---|---|
| 12 jun 2026 | II | Crystallization; identified as Buprenorphine free base | Par Health USA, LLC |
| 13 mar 2026 | II | Crystallization; identified as Buprenorphine free base | ENDO USA, Inc. |
| 20 may 2024 | II | Lack of Assurance of Sterility-The potential for incomplete crimp seals. | Pfizer Inc. |
| 3 may 2023 | II | CGMP Deviations | SUN PHARMACEUTICAL INDUSTRIES INC |
| 15 feb 2023 | III | Failed Impurities/Degradation Specifications: Out of specification for related substance 10-hydroxy buprenorphine N-Oxide results generated at the 18-month stability timepoint. | AVEVA Drug Delivery Systems, Inc. |
| 15 feb 2023 | III | Failed Impurities/Degradation Specifications: Out of specification for related substance 10-hydroxy buprenorphine N-Oxide results generated at the 18-month stability timepoint. | AVEVA Drug Delivery Systems, Inc. |
| 22 dic 2022 | II | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Pharmacy Innovations |
| 18 oct 2022 | II | Presence of Foreign Substance | SUN PHARMACEUTICAL INDUSTRIES INC |
| 9 nov 2021 | II | Crystallization; identified as Buprenorphine free base | PAR Sterile Products LLC |
| 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. |
| 15 mar 2021 | II | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. |
| 26 feb 2021 | II | Subpotent drug: Out of specification for assay of naloxone and buprenorphine (low) | Alvogen, Inc |
| 4 sept 2020 | II | Failed Stability Specifications: Below specification result for buprenorphine release rate. | Teva Pharmaceuticals USA |
| 14 ago 2020 | II | Sub-potent Drug: Out-of-Specification assay results found at 3 month stability testing. | Hikma Pharmaceuticals USA Inc. |
| 10 mar 2020 | II | Subpotent Drug | Matthew 7:25 Inc dba Thrive Pharmacy |
| 10 mar 2020 | II | Subpotent Drug | Matthew 7:25 Inc dba Thrive Pharmacy |
| 29 jun 2017 | III | Failed Impurities/Degradation Specifications: out of specification test results for related compounds largest unknown impurity. | Teva Pharmaceuticals USA |
| 29 jun 2017 | III | Failed Impurities/Degradation Specifications: out of specification test results for related compounds largest unknown impurity. | Teva Pharmaceuticals USA |
| 28 abr 2017 | II | Crystallization: due to the presence of white, crystalline particulates, adhered to the side and bottom of the glass vials, which are comprised of principally dextrose and the buprenorphine active component. | PAR Sterile Products LLC |
| 7 feb 2017 | II | Failed Impurities/Degradation Specifications | Teva Pharmaceuticals USA |
| 26 jul 2016 | II | Lack of Assurance of Sterility | Pharmacy Plus, Inc. dba Vital Care Compounder |
| 9 sept 2014 | II | Failed Impurities/Degradation Specification: Out of Specification results for pseudobuprenorphine impurity at the 9-month stability time point. | Hospira Inc. |
| 7 abr 2014 | II | Failed Impurities/Degradation Specifications: High out of specification impurity test results were obtained during stability testing. | Teva Pharmaceuticals USA |
| 7 abr 2014 | II | Failed Impurities/Degradation Specifications: High out of specification impurity test results were obtained during stability testing. | Teva Pharmaceuticals USA |
| 26 jul 2013 | II | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance | Beacon Hill Medical Pharmacy, P.C. |
| 2 jul 2013 | II | Labeling: Label Mixup: BUPRENORPHINE HCL SL, Tablet, 2 mg may be potentially mislabeled as one of the following drugs: DOCUSATE SODIUM, Capsule, 250 mg, NDC 00904789159, Pedigree: AD37072_4, EXP: 5/13/2014; MAGNESIUM CHLORIDE DR, Tablet, 64 mg, NDC 00904791152, Pedigree: AD54510_1, EXP: 2/28/2014. | Aidapak Services, LLC |
| 29 may 2013 | II | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Lowlite Investments, Inc. D/B/A Olympia Pharmacy |
| 10 abr 2013 | II | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. | FVS Holdings, Inc. dba. Green Valley Drugs |
| 25 mar 2013 | II | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance | Pallimed Solutions |
Clase I = probabilidad razonable de daño grave · Clase II = temporal o reversible · Clase III = improbable que cause daño.
Estado de registro
Algunos productos de Clinical Solutions Wholesale, 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.