Perfil del fabricante
Aphena Pharma Solutions - Tennessee, LLC
Compañía farmacéutica14 productos registrados
14
productos registrados
218.089
notificaciones totales
81
retiradas registradas
62,9%
graves en total
Productos
mostrando 14 de 14
| Producto | Aprobado | Notificaciones ↓ | Señal principal | Retiradas |
|---|---|---|---|---|
| 1981 | 46.183 | Parto prematuro | 21 | |
| 1979 | 37.162 | Eritema en el lugar de aplicación | 10 | |
| 1999 | 25.682 | Secreción rectal | 0 | |
| 1957 | 19.125 | Enfermedad renal crónica | 16 | |
| — | 15.501 | Enfermedad renal crónica | 3 | |
| — | 15.493 | Enfermedad renal crónica | 0 | |
| — | 13.473 | colitis | 1 | |
| 1998 | 10.888 | toxicidad pulmonar | 4 | |
| 1987 | 8752 | Enfermedad renal terminal | 0 | |
| 1987 | 8752 | Enfermedad renal terminal | 0 | |
| 1979 | 8547 | Esclerosis múltiple | 10 | |
| 1999 | 6069 | infarto cerebral | 5 | |
| — | 2169 | vértigo | 0 | |
| — | 293 | Accidente de tráfico | 11 |
Historial de retiradas · 50 registradas
| Fecha | Clase | Motivo | Empresa |
|---|---|---|---|
| 16 mar 2026 | II | Failed tablet specifications. | Amerisource Health Services LLC |
| 19 oct 2023 | II | Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point. | Zydus Pharmaceuticals (USA) Inc |
| 19 oct 2023 | II | Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point. | Zydus Pharmaceuticals (USA) Inc |
| 19 oct 2023 | II | Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point. | Zydus Pharmaceuticals (USA) Inc |
| 21 sept 2023 | II | Failed Dissolution Specifications | Zydus Pharmaceuticals (USA) Inc |
| 27 jun 2022 | I | Subpotent and Superpotent Drug | Valor Compounding Pharmacy, Inc DBA Valor Compounding Pharmacy |
| 13 abr 2022 | II | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office |
| 8 mar 2022 | I | Labeling: Label mix-up: Incorrect label placed on product. Shipper cases labeled Meclizine Hydrochloride Tablets contain bottles incorrectly labeled as PredniSONE Tablets. The tablets in the bottles are Meclizine Hydrochloride | Jubilant Cadista Pharmaceuticals, Inc. |
| 2 sept 2021 | II | Labeling: Incorrect Instructions | RISING PHARMACEUTICALS |
| 2 jul 2021 | II | Failed Dissolution Specification: Out of specification for dissolution during routine stability testing. | The Harvard Drug Group |
| 4 feb 2021 | II | Failed Dissolution Specifications | Wilshire Pharmaceuticals Inc |
| 4 feb 2021 | II | Failed Dissolution Specifications | Wilshire Pharmaceuticals Inc |
| 17 ago 2020 | I | Labeling: Label Mix-Up; potential for cartons labeled as Tranexamic Acid Injection, USP to contain vials of Amiodarone HCl Injection, USP and cartons labeled as Amiodarone HCl Injection, USP to contain vials of Tranexamic Acid Injection, USP. | Mylan Institutional LLC |
| 11 nov 2019 | III | Crystallization: Presence of visible particulate matter. | AuroMedics Pharma LLC |
| 11 nov 2019 | III | Crystallization: Presence of visible particulate matter. | AuroMedics Pharma LLC |
| 11 nov 2019 | III | Crystallization: Presence of visible particulate matter. | AuroMedics Pharma LLC |
| 1 oct 2019 | III | Subpotent Drug | Sato Pharmaceutical Inc. |
| 1 oct 2019 | III | Subpotent Drug | Sato Pharmaceutical Inc. |
| 1 oct 2019 | III | Subpotent Drug | Sato Pharmaceutical Inc. |
| 1 oct 2019 | III | Subpotent Drug | Sato Pharmaceutical Inc. |
| 1 mar 2019 | III | Failed Dissolution Specifications | AVKARE Inc. |
| 21 feb 2019 | III | Failed Dissolution Specifications | Lannett Company Inc. |
| 11 dic 2018 | II | Labeling: Wrong bar code | KVK-Tech, Inc. |
| 30 oct 2017 | III | Marketed without an approved NDA/ANDA: Bottles were released prior to final approval. | Jubilant Cadista Pharmaceuticals, Inc. |
| 7 mar 2017 | III | Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib | Alvogen, Inc |
| 7 mar 2017 | III | Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib | Alvogen, Inc |
| 7 mar 2017 | III | Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib | Alvogen, Inc |
| 7 mar 2017 | III | Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib | Alvogen, Inc |
| 7 mar 2017 | III | Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib | Alvogen, Inc |
| 7 mar 2017 | III | Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib | Alvogen, Inc |
| 7 mar 2017 | III | Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib | Alvogen, Inc |
| 7 mar 2017 | III | Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib | Alvogen, Inc |
| 7 mar 2017 | III | Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib | Alvogen, Inc |
| 13 oct 2016 | III | Presence of Foreign Tablets/Capsules | Amerisource Health Services |
| 6 oct 2016 | III | Presence of Foreign Tablets/Capsules | Actavis Elizabeth LLC |
| 25 mar 2016 | II | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy |
| 25 nov 2015 | III | Failed Impurities/Degradation Specifications: Out of specification for impurities. | Golden State Medical Supply Inc. |
| 25 nov 2015 | III | Failed Impurities/Degradation Specifications: Out of specification for impurities. | Golden State Medical Supply Inc. |
| 2 nov 2015 | III | Failed Impurities/Degradation Specifications: Out of specification for impurities. | Mylan Institutional, Inc. (d.b.a. UDL Laboratories) |
| 26 oct 2015 | III | Failed Impurities/Degradation Specifications: Out of specification for impurities. | Par Pharmaceutical Inc. |
| 26 oct 2015 | III | Failed Impurities/Degradation Specifications: Out of specification for impurities. | Par Pharmaceutical Inc. |
| 17 abr 2015 | II | Failed Dissolution Specifications: High out of specification dissolution result at 1 hour time point. | Valeant Pharmaceuticals North America LLC |
| 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 |
| 7 feb 2014 | III | Subpotent Drug: Drug potency was compromised during shipment. | Actavis |
| 1 nov 2013 | II | Labeling: Incorrect or Missing Lot and/or Exp Date: Greenstone LLC is recalling Nifedipine Extended Release tablets (90mg). The expiration date on the package is 48 months instead of 36 months. | Greenstone Llc |
| 2 jul 2013 | II | Labeling:Label Mixup; NIFEdipine, Capsule, 10 mg may be potentially mislabeled as NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALS, Capsule, 100 mg, NDC 47781030301, Pedigree: AD52778_58, EXP: 5/20/2014. | Aidapak Services, LLC |
| 2 jul 2013 | II | Labeling: Label Mixup: OXYBUTYNIN CHLORIDE, Tablet, 5 mg may have potentially been mislabeled as one of the following drugs: FLECAINIDE ACETATE, Tablet, 100 mg, NDC 00054001125, Pedigree: AD56847_4, EXP: 5/21/2014; SODIUM CHLORIDE, Tablet, 1 gm, NDC 00223176001, Pedigree: W003792, EXP: 6/27/2014; VARENICLINE, Tablet, 0.5 mg, NDC 00069046856, Pedigree: AD22616_1, EXP: 5/2/2014. | Aidapak Services, LLC |
| 2 jul 2013 | II | Labeling:Label Mixup; CILOSTAZOL Tablet, 100 mg may be potentially mislabeled as DUTASTERIDE, Capsule, 0.5 mg, NDC 00173071204, Pedigree: AD65475_1, EXP: 5/28/2014. | Aidapak Services, LLC |
| 2 jul 2013 | II | Labeling: Label Mixup: OXYBUTYNIN CHLORIDE, Tablet, 2.5 mg (1/2 of 5 mg) may have potentially been mislabeled as the following drug: PIMOZIDE, Tablet, 1 mg (1/2 of 2 mg), NDC 57844018701, Pedigree: AD73525_61, EXP: 5/30/2014. | Aidapak Services, LLC |
| 2 jul 2013 | II | Labeling: Label Mixup: CILOSTAZOL, Tablet, 100 mg may be potentially mislabeled as the following drug: CALCIUM ACETATE, Capsule, 667 mg, NDC 00054008826, Pedigree: W003469, EXP: 6/20/2014. | Aidapak Services, LLC |
Clase I = probabilidad razonable de daño grave · Clase II = temporal o reversible · Clase III = improbable que cause daño.
Estado de registro
Algunos productos de Aphena Pharma Solutions - 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.