Fabrikant-profiel
Baxter Healthcare Company
Farmaceutisch bedrijf3 producten gevolgd
3
producten gevolgd
197.972
totaal meldingen
34
recalls geregistreerd
96,3%
ernstig algeheel
Producten
3 van 3 getoond
| Product | Goedgekeurd | Meldingen ↓ | Top signaal | Recalls |
|---|---|---|---|---|
| — | 172.252 | koortsige neutropenie | 0 | |
| 1987 | 20.887 | Terugkerend diffuus grootcellig B-cellymfoom | 3 | |
| 1964 | 4.833 | appendicoliet | 31 |
Recall-geschiedenis · 24 geregistreerd
| Datum | Klasse | Reden | Bedrijf |
|---|---|---|---|
| 8 mrt 2022 | II | Super Potent and Failed Reconstitution Time | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| 8 mrt 2022 | II | Product found to be Sub Potent or Exceeded reconstitution time | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| 8 mrt 2022 | III | Sub Potent | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| 8 mrt 2022 | II | Sub Potent | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| 8 mrt 2022 | III | Super Potent | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| 20 nov 2020 | II | CGMP deviations: Lack of potency testing. | Complete Pharmacy and Medical Solutions, LLC. |
| 20 nov 2020 | II | CGMP deviations: Lack of potency testing. | Complete Pharmacy and Medical Solutions, LLC. |
| 20 nov 2020 | II | CGMP deviations: Lack of potency testing. | Complete Pharmacy and Medical Solutions, LLC. |
| 20 nov 2020 | II | CGMP deviations: Lack of potency testing. | Complete Pharmacy and Medical Solutions, LLC. |
| 12 jun 2019 | II | Lack of Assurance of Sterility | Infusion Options, Inc. |
| 10 sep 2018 | II | Lack of Assurance of Sterility | Pharm D Solutions, LLC |
| 10 sep 2018 | II | Lack of Assurance of Sterility | Pharm D Solutions, LLC |
| 10 sep 2018 | II | Lack of Assurance of Sterility | Pharm D Solutions, LLC |
| 10 sep 2018 | II | Lack of Assurance of Sterility | Pharm D Solutions, LLC |
| 10 sep 2018 | II | Lack of Assurance of Sterility | Pharm D Solutions, LLC |
| 15 aug 2017 | II | Lack of Assurance of Sterility. | Bella Pharmaceuticals, Inc. |
| 8 mrt 2016 | II | Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin. | Hospira Inc. |
| 2 jun 2015 | II | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America |
| 27 aug 2014 | II | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance. | Martin Avenue Pharmacy, Inc. |
| 27 aug 2014 | II | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance. | Martin Avenue Pharmacy, Inc. |
| 12 mei 2014 | II | Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products. | John W Hollis Inc |
| 13 sep 2013 | II | Temperature abuse: Certain vials of Ifosfamide IV products were not refrigerated at certain Amerisource Bergen Drug Corp distribution centers. | AmeriSource Bergen |
| 13 sep 2013 | II | Temperature abuse: Certain vials of Ifosfamide IV products were not refrigerated at certain Amerisource Bergen Drug Corp distribution centers. | AmeriSource Bergen |
| 28 mei 2013 | II | The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. | Main Street Family Pharmacy, LLC |
Class I = redelijke kans op ernstige schade · Class II = tijdelijk of omkeerbaar · Class III = onwaarschijnlijk schadelijk.
Registratiestatus
Sommige producten van Baxter Healthcare Company 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.