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AvKARE

Pharmaunternehmen18 erfasste Produkte
18
erfasste Produkte
492.099
Meldungen insgesamt
61
dokumentierte Rückrufe
64,6%
schwerwiegend insgesamt
Produkte
18 von 18 angezeigt
ProduktZugelassenMeldungen ↓Top-SignalRückrufe
200679.359Abnorme Träume0
200169.168Schwangerschaft mit Verhütungsimplantat0
200652.242Erhöhtes Prolaktin im Blut5
201743.131Sprue-ähnliche Enteropathie15
201740.089Idiopathische Lungenfibrose2
200733.035Bradykardie0
—22.046Hyperkoagulation0
200121.862Schlafstörung wegen einer allgemeinen Erkrankung23
198721.038Erhöhtes Bilirubin im Blut0
200118.444Cytomegalievirus-Virämie0
200118.444Cytomegalievirus-Virämie0
—17.015Unzureichend kontrollierter Blutdruck0
200715.403Hand-Fuß-Syndrom0
197910.411Methämoglobinämie5
200910.054Amaurosis fugax6
200910.002Amaurosis fugax0
—7.394Sprue-ähnliche Enteropathie3
20062.962Verlangsamter Herzschlag2
Rückrufhistorie · 50 dokumentiert
DatumKlasseGrundFirma
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. Dez. 2025IIOut of specification for dissolution.AvKARE
2. Sept. 2025IIFailed Content Uniformity SpecificationsAvKARE
26. Juni 2025IIIFailed Impurity/Degradation SpecificationsAvKARE
26. Juni 2025IIIFailed Impurity/Degradation SpecificationsAvKARE
11. Juni 2025IIIFailed Impurities/Degradation Specifications.Orient Pharma Co., Ltd. Yunlin Plant
11. Juni 2025IIIFailed Impurities/Degradation Specifications.Orient Pharma Co., Ltd. Yunlin Plant
13. Mai 2025IIPresence of Foreign Tablets/Capsules: manufacturer recalled because one tadalafil 5mg tablet was found in 500 count bottle of Celecoxib 200 mg capsulesAvKARE
9. Mai 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. Dez. 2024IIILABELING: LABEL MIX-UPAvKARE
18. Dez. 2024IIILABELING: LABEL MIX-UPAvKARE
10. Dez. 2024IICrystallizationVIONA PHARMACEUTICALS INC
10. Dez. 2024IICrystallizationVIONA PHARMACEUTICALS INC
4. Dez. 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. Sept. 2024IICrystallizationVIONA PHARMACEUTICALS INC
28. März 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. Dez. 2022IIFailed impurities/degradation specifications: Out of specification for unknown impurities.AVKARE LLC
22. Dez. 2022IILack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.Pharmacy Innovations
20. Juli 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. Juni 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. März 2021IICGMP Deviations: Intermittent exposure to temperature excursion during storage.Cardinal Health Inc.
7. Dez. 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. Juni 2020IICGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake levelAVKARE Inc.
4. Juni 2020IICGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake levelAVKARE Inc.
28. Mai 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.

Klasse I = begründete Wahrscheinlichkeit schwerwiegender Schäden · Klasse II = vorübergehend oder reversibel · Klasse III = Schaden unwahrscheinlich.

Registrierungsstatus

Einige Produkte von AvKARE sind nicht für die Anwendung am Menschen FDA-registriert. Für nicht registrierte Substanzen (Peptide, SARMs ohne Humanzulassung) existiert kein legitimer Anbieter für die Anwendung am Menschen. Das Fehlen eines Bezugswegs ist die Sicherheitsinformation.