Herstellerprofil
Advanced Rx of Tennessee, LLC
Pharmaunternehmen5 erfasste Produkte
5
erfasste Produkte
604.577
Meldungen insgesamt
85
dokumentierte Rückrufe
51,2%
schwerwiegend insgesamt
Produkte
5 von 5 angezeigt
| Produkt | Zugelassen | Meldungen ↓ | Top-Signal | Rückrufe |
|---|---|---|---|---|
| 1981 | 291.471 | Problem mit dem Verabreichungssystem des Geräts | 42 | |
| 1995 | 289.568 | Problem mit dem Verabreichungssystem des Geräts | 30 | |
| 1981 | 12.337 | Atopische Dermatitis | 12 | |
| 2002 | 6.966 | Rückgerufenes Produkt verabreicht | 1 | |
| 2007 | 4.235 | Ausschlag an der Anwendungsstelle | 0 |
Rückrufhistorie · 43 dokumentiert
| Datum | Klasse | Grund | Firma |
|---|---|---|---|
| 17. März 2026 | II | Labelling: Illegible label | Nephron SC, LLC |
| 24. Juli 2025 | III | Failed Stability Specifications: Out of specification results was observed in Induction Port during the analysis of Particle size distribution at the 12-month time point. | Cipla USA, Inc. |
| 14. Mai 2025 | II | Defective delivery system | AsttraZeneca Pharmaceuticals LP |
| 26. März 2024 | II | Short fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch. | Cipla USA, Inc. |
| 27. Juni 2023 | I | Defective container: empty inhaler and leakage observed through the inhaler valve due to partially missing bottom seat (gasket). | Cipla USA, Inc. |
| 26. Apr. 2023 | II | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. |
| 22. Dez. 2022 | II | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Pharmacy Innovations |
| 13. Apr. 2022 | III | 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 |
| 26. Jan. 2022 | II | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | CARDINAL HEALTHCARE |
| 26. Jan. 2022 | II | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | CARDINAL HEALTHCARE |
| 26. Jan. 2022 | II | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | CARDINAL HEALTHCARE |
| 15. März 2021 | II | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. |
| 15. März 2021 | II | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. |
| 16. Sept. 2020 | II | Defective Delivery System: Sustained trend of failure to dispense complaints. | Perrigo Company PLC |
| 12. Nov. 2019 | II | Lack of Processing Controls | Integrated Health Concepts Inc. dba Conversio Health |
| 12. Nov. 2019 | II | Lack of Processing Controls | Integrated Health Concepts Inc. dba Conversio Health |
| 12. Nov. 2019 | II | Lack of Processing Controls | Integrated Health Concepts Inc. dba Conversio Health |
| 12. Nov. 2019 | II | Lack of Processing Controls | Integrated Health Concepts Inc. dba Conversio Health |
| 12. Nov. 2019 | II | Lack of Processing Controls | Integrated Health Concepts Inc. dba Conversio Health |
| 12. Nov. 2019 | II | Lack of Processing Controls | Integrated Health Concepts Inc. dba Conversio Health |
| 12. Nov. 2019 | II | Lack of Processing Controls | Integrated Health Concepts Inc. dba Conversio Health |
| 12. Nov. 2019 | II | Lack of Processing Controls | Integrated Health Concepts Inc. dba Conversio Health |
| 3. Apr. 2018 | II | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. |
| 25. Juli 2017 | III | Failed Impurities/Degradation Specifications: high out of specification results for related compound D. | Teva Pharmaceuticals USA |
| 16. Mai 2017 | II | Defective Delivery System: Elevated number of units with out of specification results for leak rate | GlaxoSmithKline, LLC |
| 22. März 2017 | II | Defective Delivery System: Elevated number of units with out of specification results for leak rate. | GlaxoSmithKline, LLC |
| 12. Jan. 2017 | III | Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant. | Actavis Inc |
| 22. Juni 2016 | II | Presence of Foreign Substance; presence of black particles describes generically as cellulose-based bundles of brown fibrous material. | Teva North America |
| 3. Dez. 2015 | II | Defective Delivery System: Some canisters may not contain sufficient propellant to deliver the labeled claim of 200 actuations through the end of shelf life. | GlaxoSmithKline, LLC |
| 21. Aug. 2015 | II | Lack of Assurance of Sterility; potential exposure to non-sterile lubricant during the filling process | Nephron Pharmaceuticals Corp. |
| 24. Juli 2015 | II | Defective Delivery System: Inhalers do not spray properly, emitting either no spray or a short transient spray. | Boehringer Ingelheim Roxane Inc |
| 14. Nov. 2014 | II | Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin. | Attix Pharmaceuticals |
| 2. Okt. 2013 | II | Lack of Assurance of Sterility: Nephron Pharmaceuticals Corporation conducted a routine periodic aseptic process simulation and discovered bacterial growth in a number of media fill vials, exceeding the allowable limit. | Nephron Pharmaceuticals Corp. |
| 2. Juli 2013 | II | Labeling: Label Mixup: ALBUTEROL SULFATE ER, Tablet, 4 mg may have potentially been mislabeled as one of the following drugs: SIMVASTATIN, Tablet, 20 mg, NDC 16714068303, Pedigree: W003580, EXP: 6/24/2014. | Aidapak Services, LLC |
| 26. Juli 2012 | II | Does Not Deliver Proper Metered Dose: Potential content of albuterol per dose is below specification. | GlaxoSmithKline Inc |
| 22. Juni 2011 | II | Lack of Assurance of Sterility | Nephron Pharmaceuticals Corp. |
Klasse I = begründete Wahrscheinlichkeit schwerwiegender Schäden · Klasse II = vorübergehend oder reversibel · Klasse III = Schaden unwahrscheinlich.
Registrierungsstatus
Einige Produkte von Advanced Rx 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.