Manufacturer profile
Advanced Rx Pharmacy of Tennessee, LLC
Pharmaceutical company7 products tracked
7
products tracked
534,096
total reports
399
recalls on record
78.9%
serious overall
Products
showing 7 of 7
| Product | Approved | Reports ↓ | Top signal | Recalls |
|---|---|---|---|---|
| 1958 | 303,290 | Plasma cell myeloma | 81 | |
| 1957 | 167,055 | Infusion related reaction | 93 | |
| 1964 | 17,730 | Myelosuppression | 64 | |
| 1983 | 16,671 | Chondrolysis | 100 | |
| 1983 | 14,926 | Chondrolysis | 10 | |
| 1959 | 7,797 | Food allergy | 43 | |
| — | 6,627 | Pulmonary mass | 8 |
Recall history · 50 on record
| Date | Class | Reason | Firm |
|---|---|---|---|
| Apr 2, 2026 | II | Lack of Assurance of Sterility | Huons Co., Ltd. |
| Feb 4, 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 |
| Jan 15, 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 |
| Dec 18, 2025 | II | Presence of particulate matter - Glass like particles. | Imprimis NJOF, LLC |
| Dec 18, 2025 | II | Presence of particulate matter - Glass like particles. | Imprimis NJOF, LLC |
| Apr 15, 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 |
| Mar 6, 2025 | II | Lack of Assurance of Sterility | QuVa Pharma, Inc. |
| May 23, 2024 | II | Failed Impurities/Degradation Specifications: impurity sulfonic acid adduct of dexamethasone phosphate results were above spec. | Eugia US LLC |
| May 14, 2024 | II | Lack of Assurance of Sterility | Imprimis NJOF, LLC |
| May 14, 2024 | II | Lack of Assurance of Sterility | Imprimis NJOF, LLC |
| Apr 25, 2024 | II | Presence of Particulate Matter: Potential for black particulates in the drug product. | Sagent Pharmaceuticals |
| Feb 20, 2024 | II | Failed Dissolution Specifications | Eugia US LLC |
| Nov 9, 2023 | II | Lack of Assurance of Sterility | SCA Pharmaceuticals, LLC |
| Sep 21, 2023 | II | Lack of assurance of sterility: | Central Admixture Pharmacy Services Inc |
| Jul 17, 2023 | II | Lack of assurance of sterility: Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services Inc |
| May 8, 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 |
| Dec 27, 2022 | II | Lack of sterility assurance | Sentara Infusion Services |
| Dec 22, 2022 | II | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Pharmacy Innovations |
| Nov 22, 2022 | II | Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product. | Fresenius Kabi USA, LLC |
| Jul 27, 2022 | II | Lack of Assurance of Sterility | Pine Pharmaceuticals, LLC |
| Jun 30, 2022 | II | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC |
| Apr 13, 2022 | II | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | II | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | II | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | II | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | II | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | II | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | II | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | II | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | II | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | II | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | II | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | II | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | II | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | II | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | II | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | II | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 1, 2022 | III | Subpotent | Jubilant Cadista Pharmaceuticals, Inc. |
| Feb 21, 2022 | II | Failed Impurities/Degradation Specifications: higher than permissible levels of unknown impurities were found in the drug product. | Morton Grove Pharmaceuticals, Inc. |
| Dec 31, 2021 | II | Lack of Assurance of Sterility | Teva Pharmaceuticals USA |
| Dec 6, 2021 | II | CGMP Deviations | Edge Pharma, LLC |
| Dec 6, 2021 | II | Lack of Assurance of Sterility | Edge Pharma, LLC |
| Jul 29, 2021 | II | Lack of Assurance of Sterility | Teva Pharmaceuticals USA |
| Jul 29, 2021 | II | Lack of Assurance of Sterility | Teva Pharmaceuticals USA |
| May 3, 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 |
| Apr 26, 2021 | II | Lack of Assurance of Sterility | Teva Pharmaceuticals USA |
| Mar 19, 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 |
| Feb 19, 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. |
| Dec 17, 2020 | II | Lack of assurance of sterility: 13 vials were discovered to have faulty crimps. | Imprimis NJOF, LLC |
| Dec 10, 2020 | II | Subpotent Drug: Low out-of-specification assay results for the epinephrine component. | Fresenius Kabi USA, LLC |
Class I = reasonable probability of serious harm · Class II = temporary or reversible · Class III = unlikely to cause harm.
Registration status
Some products from Advanced Rx Pharmacy of Tennessee, LLC are not FDA-registered for human use. For unregistered substances (peptides, SARMs without human registration), no legitimate human-use supplier exists. The absence of a sourcing route is the safety information.