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Atlantis Consumer Healthcare, Inc.

Compañía farmacéutica4 productos registrados
4
productos registrados
21.361
notificaciones totales
68
retiradas registradas
75,9%
graves en total
Productos
mostrando 4 de 4
ProductoAprobadoNotificaciones ↓Señal principalRetiradas
—7960Parophthalmia0
19857960Síndrome tóxico del segmento anterior42
19854083Síndrome tóxico del segmento anterior26
—1358Neutropenia febril0
Historial de retiradas · 33 registradas
FechaClaseMotivoEmpresa
4 jun 2026IIsub potencyElevate Oral Care
19 ago 2025IIISubpotent drugMedline Industries, LP
13 feb 2025IIDefective Container: broken or leaking bottles.World Perfumes Inc.
11 sept 2024IIIncorrect/Undeclared Excipients: The inactive ingredients labeled on the product boxes and tubes are listed as "mineral oil , petrolatum ". The inactive ingredients in the actual product are polyethylene glycol 400 , polyethylene glycol 4000.Zhejiang Jingwei Pharmaceutical Co., Ltd.
19 oct 2023IICGMP Deviations: Recall due to the absence of USP CGMP compendial requirements.Safecor Health, LLC
9 ago 2023IICGMP Deviations: Products not manufactured under current good manufacturing practices.Ecometics, Inc.
1 dic 2022ILabeling: Label Error on Declared Strength: syringes mislabeled as 300 mg iodine/mL contained product 350 mg iodine/mLBayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy
13 abr 2022IIcGMP deviations: Temperature abuseMckesson Medical-Surgical Inc. Corporate Office
6 dic 2021IILack of Assurance of SterilityEdge Pharma, LLC
26 ago 2021IISubpotent DrugAVRIO HEALTH L.P
23 jul 2021IISubPotent: Out of SpecificationProfessional Disposables International, Inc
23 jul 2021IISubPotent: Out of SpecificationProfessional Disposables International, Inc
23 jul 2021IISubPotent: Out of SpecificationProfessional Disposables International, Inc
23 jul 2021IISubPotent: Out of SpecificationProfessional Disposables International, Inc
23 jul 2021IISubPotent: Out of SpecificationProfessional Disposables International, Inc
12 abr 2021IIDefective container; syringe content migrating past the seal of the plunger may cause a lack of assurance of sterilityEdge Pharma, LLC
18 sept 2019IILack of sterility assurance.Avella of Deer Valley, Inc. Store 38
13 sept 2019IILabeling: Not Elsewhere Classified: RFID formatting error which reads product in Ultraject syringe as expired and will not allow injection of product by the Optivantage injector.GUERBET LLC
15 feb 2018IISubpotent Drug: product not meeting the iodine assay level requirements through the labeled expiry.Medline Industries Inc
5 oct 2017IISubpotent Drug: The laminate used to make the pouches was reversed such that the aluminum layer was in contact with the product causing an exothermic reaction between the free iodine and the aluminum.Purdue Pharma, LP
21 sept 2017IISubpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.Medline Industries Inc
4 ago 2017IILabeling: Label mix-up. Finished product Povidone iodine 7.5% was labeled as Povidone iodine 10% , the outer box had the correct label.Degasa Sa De Cv
6 ago 2015IIChemical contamination: Product may be contaminated with a toxic compound.3M Company - Health Care Business
15 may 2015IILabeling: incorrect or missing lot number and/or expiration dateMallinckrodt, Inc.
20 dic 2013IISubpotent Drug: CareFusion is recalling the CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail Cleaner. The available iodine in the product is less than as stated on the product label.Carefusion 2200 Inc
20 dic 2013IISubpotent Drug: CareFusion is recalling the CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail Cleaner. The available iodine in the product is less than as stated on the product label.Carefusion 2200 Inc
21 jun 2013IIPresence of foreign substance: One lot of the product may contain black foreign particlesBracco Diagnostics Inc
29 may 2013IILack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processesLowlite Investments, Inc. D/B/A Olympia Pharmacy
21 may 2012IILack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.Franck's Lab Inc., d.b.a. Franck's Compounding Lab
21 may 2012IILack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.Franck's Lab Inc., d.b.a. Franck's Compounding Lab
21 may 2012IILack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.Franck's Lab Inc., d.b.a. Franck's Compounding Lab
21 may 2012IILack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.Franck's Lab Inc., d.b.a. Franck's Compounding Lab
21 may 2012IILack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.Franck's Lab Inc., d.b.a. Franck's Compounding Lab

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

Estado de registro

Algunos productos de Atlantis Consumer Healthcare, Inc. 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.