Herstellerprofil
Advanced Rx Pharmacy of Tennessee, LLC
Pharmaunternehmen7 erfasste Produkte
7
erfasste Produkte
534.096
Meldungen insgesamt
399
dokumentierte Rückrufe
78,9%
schwerwiegend insgesamt
Produkte
7 von 7 angezeigt
| Produkt | Zugelassen | Meldungen ↓ | Top-Signal | Rückrufe |
|---|---|---|---|---|
| 1958 | 303.290 | Plasmozytom | 81 | |
| 1957 | 167.055 | Infusionsbedingte Reaktion | 93 | |
| 1964 | 17.730 | Knochenmarkhemmung | 64 | |
| 1983 | 16.671 | Knorpelabbau | 100 | |
| 1983 | 14.926 | Knorpelabbau | 10 | |
| 1959 | 7.797 | Nahrungsmittelallergie | 43 | |
| — | 6.627 | Lungenmasse | 8 |
Rückrufhistorie · 50 dokumentiert
| Datum | Klasse | Grund | Firma |
|---|---|---|---|
| 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. Dez. 2025 | II | Presence of particulate matter - Glass like particles. | Imprimis NJOF, LLC |
| 18. Dez. 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. März 2025 | II | Lack of Assurance of Sterility | QuVa Pharma, Inc. |
| 23. Mai 2024 | II | Failed Impurities/Degradation Specifications: impurity sulfonic acid adduct of dexamethasone phosphate results were above spec. | Eugia US LLC |
| 14. Mai 2024 | II | Lack of Assurance of Sterility | Imprimis NJOF, LLC |
| 14. Mai 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. Sept. 2023 | II | Lack of assurance of sterility: | Central Admixture Pharmacy Services Inc |
| 17. Juli 2023 | II | Lack of assurance of sterility: Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services Inc |
| 8. Mai 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. Dez. 2022 | II | Lack of sterility assurance | Sentara Infusion Services |
| 22. Dez. 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. Juli 2022 | II | Lack of Assurance of Sterility | Pine Pharmaceuticals, LLC |
| 30. Juni 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. Dez. 2021 | II | Lack of Assurance of Sterility | Teva Pharmaceuticals USA |
| 6. Dez. 2021 | II | CGMP Deviations | Edge Pharma, LLC |
| 6. Dez. 2021 | II | Lack of Assurance of Sterility | Edge Pharma, LLC |
| 29. Juli 2021 | II | Lack of Assurance of Sterility | Teva Pharmaceuticals USA |
| 29. Juli 2021 | II | Lack of Assurance of Sterility | Teva Pharmaceuticals USA |
| 3. Mai 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. März 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. Dez. 2020 | II | Lack of assurance of sterility: 13 vials were discovered to have faulty crimps. | Imprimis NJOF, LLC |
| 10. Dez. 2020 | II | Subpotent Drug: Low out-of-specification assay results for the epinephrine component. | Fresenius Kabi USA, LLC |
Klasse I = begründete Wahrscheinlichkeit schwerwiegender Schäden · Klasse II = vorübergehend oder reversibel · Klasse III = Schaden unwahrscheinlich.
Registrierungsstatus
Einige Produkte von Advanced Rx Pharmacy of Tennessee, LLC sind nicht für die Anwendung am Menschen FDA-registriert. Für nicht registrierte Substanzen (Peptide, SARMs ohne Humanzulassung) existiert kein legitimer Anbieter für die Anwendung am Menschen. Das Fehlen eines Bezugswegs ist die Sicherheitsinformation.