Advanced Rx Pharmacy of Tennessee, LLC

Farmaceutisch bedrijf7 producten gevolgd

producten gevolgd

534.096

totaal meldingen

399

recalls geregistreerd

78,9%

ernstig algeheel

Producten

7 van 7 getoond

Product	Goedgekeurd	Meldingen ↓	Top signaal	Recalls
dexamethasone —	1958	303.290	multipel myeloom	81
methylprednisolone —	1957	167.055	infuusgerelateerde reactie	93
sodium phosphate —	1964	17.730	onderdrukking van beenmergactiviteit	64
bupivacaine —	1983	16.671	chondrolyse	100
bupivacaine hydrochloride —	1983	14.926	chondrolyse	10
methylprednisolone acetate —	1959	7.797	voedselallergie	43
diclofenac sodium and misoprostol —	—	6.627	longmassa	8

Recall-geschiedenis · 50 geregistreerd

Datum	Klasse	Reden	Bedrijf
2 apr 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 jan 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 dec 2025	II	Presence of particulate matter - Glass like particles.	Imprimis NJOF, LLC
18 dec 2025	II	Presence of particulate matter - Glass like particles.	Imprimis NJOF, LLC
15 apr 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 mrt 2025	II	Lack of Assurance of Sterility	QuVa Pharma, Inc.
23 mei 2024	II	Failed Impurities/Degradation Specifications: impurity sulfonic acid adduct of dexamethasone phosphate results were above spec.	Eugia US LLC
14 mei 2024	II	Lack of Assurance of Sterility	Imprimis NJOF, LLC
14 mei 2024	II	Lack of Assurance of Sterility	Imprimis NJOF, LLC
25 apr 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 sep 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 mei 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 dec 2022	II	Lack of sterility assurance	Sentara Infusion Services
22 dec 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 apr 2022	II	cGMP deviations: Temperature abuse	Mckesson Medical-Surgical Inc. Corporate Office
13 apr 2022	II	cGMP deviations: Temperature abuse	Mckesson Medical-Surgical Inc. Corporate Office
13 apr 2022	II	cGMP deviations: Temperature abuse	Mckesson Medical-Surgical Inc. Corporate Office
13 apr 2022	II	cGMP deviations: Temperature abuse	Mckesson Medical-Surgical Inc. Corporate Office
13 apr 2022	II	cGMP deviations: Temperature abuse	Mckesson Medical-Surgical Inc. Corporate Office
13 apr 2022	II	cGMP deviations: Temperature abuse	Mckesson Medical-Surgical Inc. Corporate Office
13 apr 2022	II	cGMP deviations: Temperature abuse	Mckesson Medical-Surgical Inc. Corporate Office
13 apr 2022	II	cGMP deviations: Temperature abuse	Mckesson Medical-Surgical Inc. Corporate Office
13 apr 2022	II	cGMP deviations: Temperature abuse	Mckesson Medical-Surgical Inc. Corporate Office
13 apr 2022	II	cGMP deviations: Temperature abuse	Mckesson Medical-Surgical Inc. Corporate Office
13 apr 2022	II	cGMP deviations: Temperature abuse	Mckesson Medical-Surgical Inc. Corporate Office
13 apr 2022	II	cGMP deviations: Temperature abuse	Mckesson Medical-Surgical Inc. Corporate Office
13 apr 2022	II	cGMP deviations: Temperature abuse	Mckesson Medical-Surgical Inc. Corporate Office
13 apr 2022	II	cGMP deviations: Temperature abuse	Mckesson Medical-Surgical Inc. Corporate Office
13 apr 2022	II	cGMP deviations: Temperature abuse	Mckesson Medical-Surgical Inc. Corporate Office
13 apr 2022	II	cGMP deviations: Temperature abuse	Mckesson Medical-Surgical Inc. Corporate Office
1 apr 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 dec 2021	II	Lack of Assurance of Sterility	Teva Pharmaceuticals USA
6 dec 2021	II	CGMP Deviations	Edge Pharma, LLC
6 dec 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 mei 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 apr 2021	II	Lack of Assurance of Sterility	Teva Pharmaceuticals USA
19 mrt 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 dec 2020	II	Lack of assurance of sterility: 13 vials were discovered to have faulty crimps.	Imprimis NJOF, LLC
10 dec 2020	II	Subpotent Drug: Low out-of-specification assay results for the epinephrine component.	Fresenius Kabi USA, LLC

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Registratiestatus

Sommige producten van Advanced Rx Pharmacy of Tennessee, LLC zijn niet FDA-geregistreerd voor humaan gebruik. Voor ongeregistreerde stoffen (peptiden, SARMs zonder humane registratie) bestaat geen legitieme leverancier voor humaan gebruik. Het ontbreken van een inkooproute is de veiligheidsinformatie.