Advanced Rx Pharmacy of Tennessee, LLC

Compañía farmacéutica7 productos registrados

productos registrados

534.096

notificaciones totales

399

retiradas registradas

78,9%

graves en total

Productos

mostrando 7 de 7

Producto	Aprobado	Notificaciones ↓	Señal principal	Retiradas
dexamethasone —	1958	303.290	Mieloma de células plasmáticas	81
methylprednisolone —	1957	167.055	Reacción relacionada con la infusión	93
sodium phosphate —	1964	17.730	Mielosupresión	64
bupivacaine —	1983	16.671	Condrólisis	100
bupivacaine hydrochloride —	1983	14.926	Condrólisis	10
methylprednisolone acetate —	1959	7797	Alergia alimentaria	43
diclofenac sodium and misoprostol —	—	6627	Masa pulmonar	8

Historial de retiradas · 50 registradas

Fecha	Clase	Motivo	Empresa
2 abr 2026	II	Lack of Assurance of Sterility	Huons Co., Ltd.
4 feb 2026	II	Failed Impurities/Degradation Specifications - OOS impurities result observed during long term stability testing at product expiry (24 months) were above specs for these impurities: Dexamethasone Sodium Phosphate EP impurity G (Impurity RU 49336) and dexamethasone formate.	SOMERSET THERAPEUTICS LLC
15 ene 2026	II	Labeling: Not Elsewhere Classified. Incorrect orientation of the blister foil applied to the blister cavities, which results in incorrect dosing information when following the directions on the foil.	Greenstone Llc
18 dic 2025	II	Presence of particulate matter - Glass like particles.	Imprimis NJOF, LLC
18 dic 2025	II	Presence of particulate matter - Glass like particles.	Imprimis NJOF, LLC
15 abr 2025	II	Labeling: Incorrect or Missing Lot and/or Expiration date: Individual vials of Dexonto 0.4%, are labeled correctly with the BUD of 12/25/2024, however, the outer box on some of the Dexonto 0.4% are labeled incorrectly with a BUD of 12/25/2025.	Nubratori, Inc
6 mar 2025	II	Lack of Assurance of Sterility	QuVa Pharma, Inc.
23 may 2024	II	Failed Impurities/Degradation Specifications: impurity sulfonic acid adduct of dexamethasone phosphate results were above spec.	Eugia US LLC
14 may 2024	II	Lack of Assurance of Sterility	Imprimis NJOF, LLC
14 may 2024	II	Lack of Assurance of Sterility	Imprimis NJOF, LLC
25 abr 2024	II	Presence of Particulate Matter: Potential for black particulates in the drug product.	Sagent Pharmaceuticals
20 feb 2024	II	Failed Dissolution Specifications	Eugia US LLC
9 nov 2023	II	Lack of Assurance of Sterility	SCA Pharmaceuticals, LLC
21 sept 2023	II	Lack of assurance of sterility:	Central Admixture Pharmacy Services Inc
17 jul 2023	II	Lack of assurance of sterility: Lack of validation data for sanitization cycles	Central Admixture Pharmacy Services Inc
8 may 2023	III	Labeling: Not Elsewhere Classified; A typographical error was observed in the NDC number on the preprinted Individual Folding Cartons (secondary packaging only). Incorrect NDC Number 70121-1573-1; Correct NDC Number 70121-1574-1.	Amneal Pharmaceuticals of New York, LLC
27 dic 2022	II	Lack of sterility assurance	Sentara Infusion Services
22 dic 2022	II	Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.	Pharmacy Innovations
22 nov 2022	II	Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.	Fresenius Kabi USA, LLC
27 jul 2022	II	Lack of Assurance of Sterility	Pine Pharmaceuticals, LLC
30 jun 2022	II	Lack of Assurance of Sterility	Nephron Sterile Compounding Center LLC
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
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
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
1 abr 2022	III	Subpotent	Jubilant Cadista Pharmaceuticals, Inc.
21 feb 2022	II	Failed Impurities/Degradation Specifications: higher than permissible levels of unknown impurities were found in the drug product.	Morton Grove Pharmaceuticals, Inc.
31 dic 2021	II	Lack of Assurance of Sterility	Teva Pharmaceuticals USA
6 dic 2021	II	CGMP Deviations	Edge Pharma, LLC
6 dic 2021	II	Lack of Assurance of Sterility	Edge Pharma, LLC
29 jul 2021	II	Lack of Assurance of Sterility	Teva Pharmaceuticals USA
29 jul 2021	II	Lack of Assurance of Sterility	Teva Pharmaceuticals USA
3 may 2021	I	Labeling: Label Mix-Up: some vials labeled to contain 0.5% Bupivacaine Hydrochloride Injection, USP may contain 1% Lidocaine HCl Injection, USP and some vials labeled to contain 1% Lidocaine HCl Injection, USP may contain 0.5% Bupivacaine Hydrochloride Injection, USP	PFIZER, INC
26 abr 2021	II	Lack of Assurance of Sterility	Teva Pharmaceuticals USA
19 mar 2021	III	Labeling: Illegible label: Manufacturer received complaint of mis-alignment print of the printed dosing instructions on the blister card.	Asclemed USA Inc. dba Enovachem Pharmaceuticals
19 feb 2021	III	Labeling: Illegible label: Customer complaint received of mis-alignment print of the printed dosing instructions on the blister card.	Jubilant Cadista Pharmaceuticals, Inc.
17 dic 2020	II	Lack of assurance of sterility: 13 vials were discovered to have faulty crimps.	Imprimis NJOF, LLC
10 dic 2020	II	Subpotent Drug: Low out-of-specification assay results for the epinephrine component.	Fresenius Kabi USA, 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 Advanced Rx Pharmacy 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.