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Atlantis Consumer Healthcare, Inc.

Société pharmaceutique4 produits suivis
4
produits suivis
21 361
total des notifications
68
rappels enregistrés
75,9%
graves au total
Produits
affichage de 4 sur 4
ProduitApprouvéNotifications ↓Signal principalRappels
—7 960Parophthalmia0
19857 960Syndrome toxique du segment antérieur42
19854 083Syndrome toxique du segment antérieur26
—1 358Neutropénie fébrile0
Historique des rappels · 33 enregistrés
DateClasseMotifFabricant
4 juin 2026IIsub potencyElevate Oral Care
19 août 2025IIISubpotent drugMedline Industries, LP
13 févr. 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 août 2023IICGMP Deviations: Products not manufactured under current good manufacturing practices.Ecometics, Inc.
1 déc. 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 avr. 2022IIcGMP deviations: Temperature abuseMckesson Medical-Surgical Inc. Corporate Office
6 déc. 2021IILack of Assurance of SterilityEdge Pharma, LLC
26 août 2021IISubpotent DrugAVRIO HEALTH L.P
23 juil. 2021IISubPotent: Out of SpecificationProfessional Disposables International, Inc
23 juil. 2021IISubPotent: Out of SpecificationProfessional Disposables International, Inc
23 juil. 2021IISubPotent: Out of SpecificationProfessional Disposables International, Inc
23 juil. 2021IISubPotent: Out of SpecificationProfessional Disposables International, Inc
23 juil. 2021IISubPotent: Out of SpecificationProfessional Disposables International, Inc
12 avr. 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 févr. 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 août 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 août 2015IIChemical contamination: Product may be contaminated with a toxic compound.3M Company - Health Care Business
15 mai 2015IILabeling: incorrect or missing lot number and/or expiration dateMallinckrodt, Inc.
20 déc. 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 déc. 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 juin 2013IIPresence of foreign substance: One lot of the product may contain black foreign particlesBracco Diagnostics Inc
29 mai 2013IILack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processesLowlite Investments, Inc. D/B/A Olympia Pharmacy
21 mai 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 mai 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 mai 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 mai 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 mai 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

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 Atlantis Consumer Healthcare, Inc. 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.