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AvKARE

Farmaceutisch bedrijf18 producten gevolgd
18
producten gevolgd
492.099
totaal meldingen
61
recalls geregistreerd
64,6%
ernstig algeheel
Producten
18 van 18 getoond
ProductGoedgekeurdMeldingen ↓Top signaalRecalls
200679.359abnormale dromen0
200169.168zwangerschap met anticonceptie-implantaat0
200652.242Verhoogd prolactinegehalte in bloed5
201743.131Spruwachtige dunnedarmziekte15
201740.089idiopathische longfibrose2
200733.035Bradycardie0
—22.046hypercoagulatie0
200121.862slaapstoornis door een algemene medische aandoening23
198721.038verhoogd bilirubinegehalte in het bloed0
200118.444Cytomegalovirus-viraemie0
200118.444Cytomegalovirus-viraemie0
—17.015onvoldoende gecontroleerde bloeddruk0
200715.403Palmar-plantair erytrodysesthesie syndroom0
197910.411methaemoglobinemie5
200910.054amaurosis fugax6
200910.002amaurosis fugax0
—7.394Spruwachtige dunnedarmziekte3
20062.962Afgenomen hartslag2
Recall-geschiedenis · 50 geregistreerd
DatumKlasseRedenBedrijf
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 dec 2025IIOut of specification for dissolution.AvKARE
2 sep 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 mei 2025IIPresence of Foreign Tablets/Capsules: manufacturer recalled because one tadalafil 5mg tablet was found in 500 count bottle of Celecoxib 200 mg capsulesAvKARE
9 mei 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 jan 2025IIOut of Specification for DissolutionAvKARE
18 dec 2024IIILABELING: LABEL MIX-UPAvKARE
18 dec 2024IIILABELING: LABEL MIX-UPAvKARE
10 dec 2024IICrystallizationVIONA PHARMACEUTICALS INC
10 dec 2024IICrystallizationVIONA PHARMACEUTICALS INC
4 dec 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 okt 2024IICrystallizationVIONA PHARMACEUTICALS INC
18 okt 2024IILabeling: Label Mix-UpAvKARE
18 okt 2024IILabeling: Label Mix-UpAvKARE
24 sep 2024IICrystallizationVIONA PHARMACEUTICALS INC
28 mrt 2024IMicrobial contamination of a non-sterile product: potential Bacillus cereus contamination.AvKARE
11 aug 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 aug 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 dec 2022IIFailed impurities/degradation specifications: Out of specification for unknown impurities.AVKARE LLC
22 dec 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 okt 2021IILack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy
12 okt 2021IILack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy
12 okt 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 apr 2021IIIPresence of Foreign Tablet/CapsuleAscend Laboratories LLC
15 mrt 2021IICGMP Deviations: Intermittent exposure to temperature excursion during storage.Cardinal Health Inc.
7 dec 2020IIProduct mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during bottling at a 3rd party facility.AVKARE Inc.
30 okt 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 mei 2020IIIPresence of Foreign Substance consistent with granules from desiccant packs used during storageAVKARE Inc.
24 jan 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 jan 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 okt 2019IICGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in APIAVKARE Inc.
17 okt 2019IICGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in APIAVKARE Inc.

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Registratiestatus

Sommige producten van AvKARE 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.