Profil du fabricant
Advanced Rx of Tennessee, LLC
Société pharmaceutique5 produits suivis
5
produits suivis
604 577
total des notifications
85
rappels enregistrés
51,2%
graves au total
Produits
affichage de 5 sur 5
| Produit | Approuvé | Notifications ↓ | Signal principal | Rappels |
|---|---|---|---|---|
| 1981 | 291 471 | Problème de système d'administration du dispositif | 42 | |
| 1995 | 289 568 | Problème de système d'administration du dispositif | 30 | |
| 1981 | 12 337 | Dermatite atopique | 12 | |
| 2002 | 6 966 | Produit rappelé administré | 1 | |
| 2007 | 4 235 | Éruption au site d'application | 0 |
Historique des rappels · 43 enregistrés
| Date | Classe | Motif | Fabricant |
|---|---|---|---|
| 17 mars 2026 | II | Labelling: Illegible label | Nephron SC, LLC |
| 24 juil. 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 mars 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 juin 2023 | I | Defective container: empty inhaler and leakage observed through the inhaler valve due to partially missing bottom seat (gasket). | Cipla USA, Inc. |
| 26 avr. 2023 | II | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. |
| 22 déc. 2022 | II | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Pharmacy Innovations |
| 13 avr. 2022 | III | 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 |
| 26 janv. 2022 | II | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | CARDINAL HEALTHCARE |
| 26 janv. 2022 | II | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | CARDINAL HEALTHCARE |
| 26 janv. 2022 | II | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | CARDINAL HEALTHCARE |
| 15 mars 2021 | II | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. |
| 15 mars 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 avr. 2018 | II | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. |
| 25 juil. 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 mars 2017 | II | Defective Delivery System: Elevated number of units with out of specification results for leak rate. | GlaxoSmithKline, LLC |
| 12 janv. 2017 | III | Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant. | Actavis Inc |
| 22 juin 2016 | II | Presence of Foreign Substance; presence of black particles describes generically as cellulose-based bundles of brown fibrous material. | Teva North America |
| 3 déc. 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 août 2015 | II | Lack of Assurance of Sterility; potential exposure to non-sterile lubricant during the filling process | Nephron Pharmaceuticals Corp. |
| 24 juil. 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 oct. 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 juil. 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 juil. 2012 | II | Does Not Deliver Proper Metered Dose: Potential content of albuterol per dose is below specification. | GlaxoSmithKline Inc |
| 22 juin 2011 | II | Lack of Assurance of Sterility | Nephron Pharmaceuticals Corp. |
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 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.