Fabrikant-profiel
Advanced Rx of Tennessee, LLC
Farmaceutisch bedrijf5 producten gevolgd
5
producten gevolgd
604.577
totaal meldingen
85
recalls geregistreerd
51,2%
ernstig algeheel
Producten
5 van 5 getoond
| Product | Goedgekeurd | Meldingen ↓ | Top signaal | Recalls |
|---|---|---|---|---|
| 1981 | 291.471 | Probleem met afgiftesysteem van hulpmiddel | 42 | |
| 1995 | 289.568 | Probleem met afgiftesysteem van hulpmiddel | 30 | |
| 1981 | 12.337 | Atopische dermatitis | 12 | |
| 2002 | 6.966 | teruggeroepen product toegediend | 1 | |
| 2007 | 4.235 | huiduitslag op de toedieningsplaats | 0 |
Recall-geschiedenis · 43 geregistreerd
| Datum | Klasse | Reden | Bedrijf |
|---|---|---|---|
| 17 mrt 2026 | II | Labelling: Illegible label | Nephron SC, LLC |
| 24 jul 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 mei 2025 | II | Defective delivery system | AsttraZeneca Pharmaceuticals LP |
| 26 mrt 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 jun 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 dec 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 mrt 2021 | II | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. |
| 15 mrt 2021 | II | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. |
| 16 sep 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 jul 2017 | III | Failed Impurities/Degradation Specifications: high out of specification results for related compound D. | Teva Pharmaceuticals USA |
| 16 mei 2017 | II | Defective Delivery System: Elevated number of units with out of specification results for leak rate | GlaxoSmithKline, LLC |
| 22 mrt 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 jun 2016 | II | Presence of Foreign Substance; presence of black particles describes generically as cellulose-based bundles of brown fibrous material. | Teva North America |
| 3 dec 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 jul 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 jul 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 jul 2012 | II | Does Not Deliver Proper Metered Dose: Potential content of albuterol per dose is below specification. | GlaxoSmithKline Inc |
| 22 jun 2011 | II | Lack of Assurance of Sterility | Nephron Pharmaceuticals Corp. |
Class I = redelijke kans op ernstige schade · Class II = tijdelijk of omkeerbaar · Class III = onwaarschijnlijk schadelijk.
Registratiestatus
Sommige producten van Advanced Rx 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.