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AvKARE

Compañía farmacéutica18 productos registrados
18
productos registrados
492.099
notificaciones totales
61
retiradas registradas
64,6%
graves en total
Productos
mostrando 18 de 18
ProductoAprobadoNotificaciones ↓Señal principalRetiradas
200679.359sueños anormales0
200169.168Embarazo con anticonceptivo implantado0
200652.242Aumento de prolactina en sangre5
201743.131Enteropatía similar a la esprue15
201740.089Fibrosis pulmonar idiopática2
200733.035Bradicardia0
—22.046Hipercoagulación0
200121.862trastorno del sueño debido a una afección médica general23
198721.038Aumento de bilirrubina en sangre0
200118.444Viremia por citomegalovirus0
200118.444Viremia por citomegalovirus0
—17.015Presión arterial mal controlada0
200715.403Síndrome de eritrodisestesia palmoplantar0
197910.411Metahemoglobinemia5
200910.054Amaurosis fugax6
200910.002Amaurosis fugax0
—7394Enteropatía similar a la esprue3
20062962Frecuencia cardíaca disminuida2
Historial de retiradas · 50 registradas
FechaClaseMotivoEmpresa
13 feb 2026IIFailed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution.AvKARE
3 feb 2026IIIPresence of foreign tablets/capsules: one Pitavastatin tablet 1mg found in bottle of Pitavastatin tablets 2mgAnnora Pharma Private Limited
31 dic 2025IIOut of specification for dissolution.AvKARE
2 sept 2025IIFailed Content Uniformity SpecificationsAvKARE
26 jun 2025IIIFailed Impurity/Degradation SpecificationsAvKARE
26 jun 2025IIIFailed Impurity/Degradation SpecificationsAvKARE
11 jun 2025IIIFailed Impurities/Degradation Specifications.Orient Pharma Co., Ltd. Yunlin Plant
11 jun 2025IIIFailed Impurities/Degradation Specifications.Orient Pharma Co., Ltd. Yunlin Plant
13 may 2025IIPresence of Foreign Tablets/Capsules: manufacturer recalled because one tadalafil 5mg tablet was found in 500 count bottle of Celecoxib 200 mg capsulesAvKARE
9 may 2025IIFailed Dissolution SpecificationsAvKARE
4 feb 2025IISubpotent 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 ene 2025IIOut of Specification for DissolutionAvKARE
18 dic 2024IIILABELING: LABEL MIX-UPAvKARE
18 dic 2024IIILABELING: LABEL MIX-UPAvKARE
10 dic 2024IICrystallizationVIONA PHARMACEUTICALS INC
10 dic 2024IICrystallizationVIONA PHARMACEUTICALS INC
4 dic 2024IIFailed Dissolution SpecificationsAvKARE
27 nov 2024IICGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.AvKARE
27 nov 2024IICGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.AvKARE
27 nov 2024IICGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.AvKARE
29 oct 2024IICrystallizationVIONA PHARMACEUTICALS INC
18 oct 2024IILabeling: Label Mix-UpAvKARE
18 oct 2024IILabeling: Label Mix-UpAvKARE
24 sept 2024IICrystallizationVIONA PHARMACEUTICALS INC
28 mar 2024IMicrobial contamination of a non-sterile product: potential Bacillus cereus contamination.AvKARE
11 ago 2023IICases 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 ToothpasteAVKARE LLC
11 ago 2023IIProduct mix-up: Cartons labeled Capsaicin Cream 0.025% may contain tubes of Sodium Fluoride 1.1% Prescription Dental ToothpasteAVKARE LLC
7 feb 2023IICGMP Deviations: recalling drug products following an FDA inspection.Accord Healthcare, Inc.
7 feb 2023IICGMP Deviations: recalling drug products following an FDA inspection.Accord Healthcare, Inc.
22 dic 2022IIFailed impurities/degradation specifications: Out of specification for unknown impurities.AVKARE LLC
22 dic 2022IILack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.Pharmacy Innovations
20 jul 2022IIILabeling: Label Error on Declared StrengthAVKARE Inc.
28 feb 2022IIFailed Dissolution SpecificationsThe Harvard Drug Group
12 oct 2021IILack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy
12 oct 2021IILack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy
12 oct 2021IILack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy
9 jun 2021IIIFailed Impurities Specification: Out of specification when measuring the impurity degradant D level.AVKARE Inc.
29 abr 2021IIIPresence of Foreign Tablet/CapsuleAscend Laboratories LLC
15 mar 2021IICGMP Deviations: Intermittent exposure to temperature excursion during storage.Cardinal Health Inc.
7 dic 2020IIProduct mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during bottling at a 3rd party facility.AVKARE Inc.
30 oct 2020IIFailed Dissolution SpecificationsAVKARE Inc.
4 jun 2020IICGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake levelAVKARE Inc.
4 jun 2020IICGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake levelAVKARE Inc.
28 may 2020IIIPresence of Foreign Substance consistent with granules from desiccant packs used during storageAVKARE Inc.
24 ene 2020IIcGMP 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 ene 2020IIFailed Impurities/Degradation Specifications: High out of specification results for related compounds.AVKARE Inc.
14 nov 2019IICGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in APIAVKARE Inc.
14 nov 2019IICGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in APIAVKARE Inc.
17 oct 2019IICGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in APIAVKARE Inc.
17 oct 2019IICGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in APIAVKARE Inc.

Clase I = probabilidad razonable de daño grave · Clase II = temporal o reversible · Clase III = improbable que cause daño.

Estado de registro

Algunos productos de AvKARE no están registrados por la FDA para uso humano. Para las sustancias no registradas (péptidos, SARM sin registro humano) no existe ningún proveedor legítimo para uso humano. La ausencia de una vía de aprovisionamiento es la información de seguridad.