Profil du fabricant
Advanced Rx Pharmacy of Tennessee, LLC
Société pharmaceutique7 produits suivis
7
produits suivis
534 096
total des notifications
399
rappels enregistrés
78,9%
graves au total
Produits
affichage de 7 sur 7
| Produit | Approuvé | Notifications ↓ | Signal principal | Rappels |
|---|---|---|---|---|
| 1958 | 303 290 | Myélome à plasmocytes | 81 | |
| 1957 | 167 055 | Réaction liée à la perfusion | 93 | |
| 1964 | 17 730 | Myélosuppression | 64 | |
| 1983 | 16 671 | Chondrolyse | 100 | |
| 1983 | 14 926 | Chondrolyse | 10 | |
| 1959 | 7 797 | Allergie alimentaire | 43 | |
| — | 6 627 | Masse pulmonaire | 8 |
Historique des rappels · 50 enregistrés
| Date | Classe | Motif | Fabricant |
|---|---|---|---|
| 2 avr. 2026 | II | Lack of Assurance of Sterility | Huons Co., Ltd. |
| 4 févr. 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 janv. 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 déc. 2025 | II | Presence of particulate matter - Glass like particles. | Imprimis NJOF, LLC |
| 18 déc. 2025 | II | Presence of particulate matter - Glass like particles. | Imprimis NJOF, LLC |
| 15 avr. 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 mars 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 avr. 2024 | II | Presence of Particulate Matter: Potential for black particulates in the drug product. | Sagent Pharmaceuticals |
| 20 févr. 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 juil. 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 déc. 2022 | II | Lack of sterility assurance | Sentara Infusion Services |
| 22 déc. 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 juil. 2022 | II | Lack of Assurance of Sterility | Pine Pharmaceuticals, LLC |
| 30 juin 2022 | II | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC |
| 13 avr. 2022 | II | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office |
| 13 avr. 2022 | II | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office |
| 13 avr. 2022 | II | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office |
| 13 avr. 2022 | II | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office |
| 13 avr. 2022 | II | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office |
| 13 avr. 2022 | II | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office |
| 13 avr. 2022 | II | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office |
| 13 avr. 2022 | II | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office |
| 13 avr. 2022 | II | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office |
| 13 avr. 2022 | II | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office |
| 13 avr. 2022 | II | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office |
| 13 avr. 2022 | II | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office |
| 13 avr. 2022 | II | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office |
| 13 avr. 2022 | II | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office |
| 13 avr. 2022 | II | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office |
| 13 avr. 2022 | II | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office |
| 1 avr. 2022 | III | Subpotent | Jubilant Cadista Pharmaceuticals, Inc. |
| 21 févr. 2022 | II | Failed Impurities/Degradation Specifications: higher than permissible levels of unknown impurities were found in the drug product. | Morton Grove Pharmaceuticals, Inc. |
| 31 déc. 2021 | II | Lack of Assurance of Sterility | Teva Pharmaceuticals USA |
| 6 déc. 2021 | II | CGMP Deviations | Edge Pharma, LLC |
| 6 déc. 2021 | II | Lack of Assurance of Sterility | Edge Pharma, LLC |
| 29 juil. 2021 | II | Lack of Assurance of Sterility | Teva Pharmaceuticals USA |
| 29 juil. 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 avr. 2021 | II | Lack of Assurance of Sterility | Teva Pharmaceuticals USA |
| 19 mars 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 févr. 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 déc. 2020 | II | Lack of assurance of sterility: 13 vials were discovered to have faulty crimps. | Imprimis NJOF, LLC |
| 10 déc. 2020 | II | Subpotent Drug: Low out-of-specification assay results for the epinephrine component. | Fresenius Kabi USA, LLC |
Classe I = probabilité raisonnable de préjudice grave · Classe II = temporaire ou réversible · Classe III = peu susceptible de causer un préjudice.
Statut d'enregistrement
Certains produits de Advanced Rx Pharmacy of Tennessee, LLC ne sont pas enregistrés auprès de la FDA pour un usage humain. Pour les substances non enregistrées (peptides, SARMs sans enregistrement humain), aucun fournisseur légitime à usage humain n'existe. L'absence de filière d'approvisionnement est l'information de sécurité.