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Atlantis Consumer Healthcare, Inc.

Pharmaunternehmen4 erfasste Produkte
4
erfasste Produkte
21.361
Meldungen insgesamt
68
dokumentierte Rückrufe
75,9%
schwerwiegend insgesamt
Produkte
4 von 4 angezeigt
ProduktZugelassenMeldungen ↓Top-SignalRückrufe
—7.960Parophthalmia0
19857.960Toxisches anteriores Segment-Syndrom42
19854.083Toxisches anteriores Segment-Syndrom26
—1.358Fieberhafte Neutropenie0
Rückrufhistorie · 33 dokumentiert
DatumKlasseGrundFirma
4. Juni 2026IIsub potencyElevate Oral Care
19. Aug. 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. Okt. 2023IICGMP Deviations: Recall due to the absence of USP CGMP compendial requirements.Safecor Health, LLC
9. Aug. 2023IICGMP Deviations: Products not manufactured under current good manufacturing practices.Ecometics, Inc.
1. Dez. 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. Apr. 2022IIcGMP deviations: Temperature abuseMckesson Medical-Surgical Inc. Corporate Office
6. Dez. 2021IILack of Assurance of SterilityEdge Pharma, LLC
26. Aug. 2021IISubpotent DrugAVRIO HEALTH L.P
23. Juli 2021IISubPotent: Out of SpecificationProfessional Disposables International, Inc
23. Juli 2021IISubPotent: Out of SpecificationProfessional Disposables International, Inc
23. Juli 2021IISubPotent: Out of SpecificationProfessional Disposables International, Inc
23. Juli 2021IISubPotent: Out of SpecificationProfessional Disposables International, Inc
23. Juli 2021IISubPotent: Out of SpecificationProfessional Disposables International, Inc
12. Apr. 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. Okt. 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. Aug. 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. Aug. 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. Dez. 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. Dez. 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. Juni 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

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

Registrierungsstatus

Einige Produkte von Atlantis Consumer Healthcare, Inc. 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.