Profil du fabricant
AvKARE
Société pharmaceutique18 produits suivis
18
produits suivis
492 099
total des notifications
61
rappels enregistrés
64,6%
graves au total
Produits
affichage de 18 sur 18
| Produit | Approuvé | Notifications ↓ | Signal principal | Rappels |
|---|---|---|---|---|
| 2006 | 79 359 | rêves anormaux | 0 | |
| 2001 | 69 168 | Grossesse avec contraceptif implanté | 0 | |
| 2006 | 52 242 | Augmentation de la prolactine sanguine | 5 | |
| 2017 | 43 131 | Entéropathie de type sprue | 15 | |
| 2017 | 40 089 | fibrose pulmonaire idiopathique | 2 | |
| 2007 | 33 035 | Bradycardie | 0 | |
| — | 22 046 | Hypercoagulation | 0 | |
| 2001 | 21 862 | trouble du sommeil dû à une condition médicale générale | 23 | |
| 1987 | 21 038 | Bilirubine sanguine augmentée | 0 | |
| 2001 | 18 444 | Viraémie à cytomégalovirus | 0 | |
| 2001 | 18 444 | Viraémie à cytomégalovirus | 0 | |
| — | 17 015 | Tension artérielle mal contrôlée | 0 | |
| 2007 | 15 403 | Syndrome d'érythrodysesthésie palmo-plantaire | 0 | |
| 1979 | 10 411 | Méthémoglobinémie | 5 | |
| 2009 | 10 054 | Amaurose fugace | 6 | |
| 2009 | 10 002 | Amaurose fugace | 0 | |
| — | 7 394 | Entéropathie de type sprue | 3 | |
| 2006 | 2 962 | Rythme cardiaque diminué | 2 |
Historique des rappels · 50 enregistrés
| Date | Classe | Motif | Fabricant |
|---|---|---|---|
| 13 févr. 2026 | II | Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution. | AvKARE |
| 3 févr. 2026 | III | Presence of foreign tablets/capsules: one Pitavastatin tablet 1mg found in bottle of Pitavastatin tablets 2mg | Annora Pharma Private Limited |
| 31 déc. 2025 | II | Out of specification for dissolution. | AvKARE |
| 2 sept. 2025 | II | Failed Content Uniformity Specifications | AvKARE |
| 26 juin 2025 | III | Failed Impurity/Degradation Specifications | AvKARE |
| 26 juin 2025 | III | Failed Impurity/Degradation Specifications | AvKARE |
| 11 juin 2025 | III | Failed Impurities/Degradation Specifications. | Orient Pharma Co., Ltd. Yunlin Plant |
| 11 juin 2025 | III | Failed Impurities/Degradation Specifications. | Orient Pharma Co., Ltd. Yunlin Plant |
| 13 mai 2025 | II | Presence of Foreign Tablets/Capsules: manufacturer recalled because one tadalafil 5mg tablet was found in 500 count bottle of Celecoxib 200 mg capsules | AvKARE |
| 9 mai 2025 | II | Failed Dissolution Specifications | AvKARE |
| 4 févr. 2025 | II | Subpotent Drug: Out of Specification (OOS) result for De hydro Impurity (0.654%) for 18 M Stability sample and low assay 94.9% (specification of NLT 95.0% NMT 105%) | AvKARE |
| 21 janv. 2025 | II | Out of Specification for Dissolution | AvKARE |
| 18 déc. 2024 | III | LABELING: LABEL MIX-UP | AvKARE |
| 18 déc. 2024 | III | LABELING: LABEL MIX-UP | AvKARE |
| 10 déc. 2024 | II | Crystallization | VIONA PHARMACEUTICALS INC |
| 10 déc. 2024 | II | Crystallization | VIONA PHARMACEUTICALS INC |
| 4 déc. 2024 | II | Failed Dissolution Specifications | AvKARE |
| 27 nov. 2024 | II | CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit. | AvKARE |
| 27 nov. 2024 | II | CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit. | AvKARE |
| 27 nov. 2024 | II | CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit. | AvKARE |
| 29 oct. 2024 | II | Crystallization | VIONA PHARMACEUTICALS INC |
| 18 oct. 2024 | II | Labeling: Label Mix-Up | AvKARE |
| 18 oct. 2024 | II | Labeling: Label Mix-Up | AvKARE |
| 24 sept. 2024 | II | Crystallization | VIONA PHARMACEUTICALS INC |
| 28 mars 2024 | I | Microbial contamination of a non-sterile product: potential Bacillus cereus contamination. | AvKARE |
| 11 août 2023 | II | Cases of Sodium Fluoride 1.1% Prescription Dental Toothpaste may contain cartons labeled as Capsaicin Cream 0.025% but contain correctly labeled tubes of Sodium Fluoride 1.1% Prescription Dental Toothpaste | AVKARE LLC |
| 11 août 2023 | II | Product mix-up: Cartons labeled Capsaicin Cream 0.025% may contain tubes of Sodium Fluoride 1.1% Prescription Dental Toothpaste | AVKARE LLC |
| 7 févr. 2023 | II | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. |
| 7 févr. 2023 | II | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. |
| 22 déc. 2022 | II | Failed impurities/degradation specifications: Out of specification for unknown impurities. | AVKARE LLC |
| 22 déc. 2022 | II | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Pharmacy Innovations |
| 20 juil. 2022 | III | Labeling: Label Error on Declared Strength | AVKARE Inc. |
| 28 févr. 2022 | II | Failed Dissolution Specifications | The Harvard Drug Group |
| 12 oct. 2021 | II | Lack of assurance of sterility | Vita Pharmacy, LLC dba Talon Compounding Pharmacy |
| 12 oct. 2021 | II | Lack of assurance of sterility | Vita Pharmacy, LLC dba Talon Compounding Pharmacy |
| 12 oct. 2021 | II | Lack of assurance of sterility | Vita Pharmacy, LLC dba Talon Compounding Pharmacy |
| 9 juin 2021 | III | Failed Impurities Specification: Out of specification when measuring the impurity degradant D level. | AVKARE Inc. |
| 29 avr. 2021 | III | Presence of Foreign Tablet/Capsule | Ascend Laboratories LLC |
| 15 mars 2021 | II | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. |
| 7 déc. 2020 | II | Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during bottling at a 3rd party facility. | AVKARE Inc. |
| 30 oct. 2020 | II | Failed Dissolution Specifications | AVKARE Inc. |
| 4 juin 2020 | II | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level | AVKARE Inc. |
| 4 juin 2020 | II | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level | AVKARE Inc. |
| 28 mai 2020 | III | Presence of Foreign Substance consistent with granules from desiccant packs used during storage | AVKARE Inc. |
| 24 janv. 2020 | II | cGMP Deviations; Olmesartan Medoximil Tablets 20 mg was released in error with alternate API source prior to filing and approval of Prior Approval Supplement. | Ascend Laboratories LLC |
| 7 janv. 2020 | II | Failed Impurities/Degradation Specifications: High out of specification results for related compounds. | AVKARE Inc. |
| 14 nov. 2019 | II | CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API | AVKARE Inc. |
| 14 nov. 2019 | II | CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API | AVKARE Inc. |
| 17 oct. 2019 | II | CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API | AVKARE Inc. |
| 17 oct. 2019 | II | CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API | AVKARE Inc. |
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 AvKARE 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.