Fabrikant-profiel
Atlantis Consumer Healthcare, Inc.
Farmaceutisch bedrijf4 producten gevolgd
4
producten gevolgd
21.361
totaal meldingen
68
recalls geregistreerd
75,9%
ernstig algeheel
Producten
4 van 4 getoond
| Product | Goedgekeurd | Meldingen ↓ | Top signaal | Recalls |
|---|---|---|---|---|
| — | 7.960 | Parophthalmia | 0 | |
| 1985 | 7.960 | Toxisch anterieur segment syndroom | 42 | |
| 1985 | 4.083 | Toxisch anterieur segment syndroom | 26 | |
| — | 1.358 | koortsige neutropenie | 0 |
Recall-geschiedenis · 33 geregistreerd
| Datum | Klasse | Reden | Bedrijf |
|---|---|---|---|
| 4 jun 2026 | II | sub potency | Elevate Oral Care |
| 19 aug 2025 | III | Subpotent drug | Medline Industries, LP |
| 13 feb 2025 | II | Defective Container: broken or leaking bottles. | World Perfumes Inc. |
| 11 sep 2024 | II | Incorrect/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 2023 | II | CGMP Deviations: Recall due to the absence of USP CGMP compendial requirements. | Safecor Health, LLC |
| 9 aug 2023 | II | CGMP Deviations: Products not manufactured under current good manufacturing practices. | Ecometics, Inc. |
| 1 dec 2022 | I | Labeling: Label Error on Declared Strength: syringes mislabeled as 300 mg iodine/mL contained product 350 mg iodine/mL | BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy |
| 13 apr 2022 | II | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office |
| 6 dec 2021 | II | Lack of Assurance of Sterility | Edge Pharma, LLC |
| 26 aug 2021 | II | Subpotent Drug | AVRIO HEALTH L.P |
| 23 jul 2021 | II | SubPotent: Out of Specification | Professional Disposables International, Inc |
| 23 jul 2021 | II | SubPotent: Out of Specification | Professional Disposables International, Inc |
| 23 jul 2021 | II | SubPotent: Out of Specification | Professional Disposables International, Inc |
| 23 jul 2021 | II | SubPotent: Out of Specification | Professional Disposables International, Inc |
| 23 jul 2021 | II | SubPotent: Out of Specification | Professional Disposables International, Inc |
| 12 apr 2021 | II | Defective container; syringe content migrating past the seal of the plunger may cause a lack of assurance of sterility | Edge Pharma, LLC |
| 18 sep 2019 | II | Lack of sterility assurance. | Avella of Deer Valley, Inc. Store 38 |
| 13 sep 2019 | II | Labeling: 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 2018 | II | Subpotent Drug: product not meeting the iodine assay level requirements through the labeled expiry. | Medline Industries Inc |
| 5 okt 2017 | II | Subpotent 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 sep 2017 | II | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. | Medline Industries Inc |
| 4 aug 2017 | II | Labeling: 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 2015 | II | Chemical contamination: Product may be contaminated with a toxic compound. | 3M Company - Health Care Business |
| 15 mei 2015 | II | Labeling: incorrect or missing lot number and/or expiration date | Mallinckrodt, Inc. |
| 20 dec 2013 | II | Subpotent 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 dec 2013 | II | Subpotent 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 2013 | II | Presence of foreign substance: One lot of the product may contain black foreign particles | Bracco Diagnostics Inc |
| 29 mei 2013 | II | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Lowlite Investments, Inc. D/B/A Olympia Pharmacy |
| 21 mei 2012 | II | Lack 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 mei 2012 | II | Lack 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 mei 2012 | II | Lack 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 mei 2012 | II | Lack 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 mei 2012 | II | Lack 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 |
Class I = redelijke kans op ernstige schade · Class II = tijdelijk of omkeerbaar · Class III = onwaarschijnlijk schadelijk.
Registratiestatus
Sommige producten van Atlantis Consumer Healthcare, Inc. 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.