Herstellerprofil
Baxter Healthcare Company
Pharmaunternehmen3 erfasste Produkte
3
erfasste Produkte
197.972
Meldungen insgesamt
34
dokumentierte Rückrufe
96,3%
schwerwiegend insgesamt
Produkte
3 von 3 angezeigt
| Produkt | Zugelassen | Meldungen ↓ | Top-Signal | Rückrufe |
|---|---|---|---|---|
| — | 172.252 | Fieberhafte Neutropenie | 0 | |
| 1987 | 20.887 | Wiederkehrendes diffuses großzelliges B-Zell-Lymphom | 3 | |
| 1964 | 4.833 | Appendikolith | 31 |
Rückrufhistorie · 24 dokumentiert
| Datum | Klasse | Grund | Firma |
|---|---|---|---|
| 8. März 2022 | II | Super Potent and Failed Reconstitution Time | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| 8. März 2022 | II | Product found to be Sub Potent or Exceeded reconstitution time | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| 8. März 2022 | III | Sub Potent | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| 8. März 2022 | II | Sub Potent | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| 8. März 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. Juni 2019 | II | Lack of Assurance of Sterility | Infusion Options, Inc. |
| 10. Sept. 2018 | II | Lack of Assurance of Sterility | Pharm D Solutions, LLC |
| 10. Sept. 2018 | II | Lack of Assurance of Sterility | Pharm D Solutions, LLC |
| 10. Sept. 2018 | II | Lack of Assurance of Sterility | Pharm D Solutions, LLC |
| 10. Sept. 2018 | II | Lack of Assurance of Sterility | Pharm D Solutions, LLC |
| 10. Sept. 2018 | II | Lack of Assurance of Sterility | Pharm D Solutions, LLC |
| 15. Aug. 2017 | II | Lack of Assurance of Sterility. | Bella Pharmaceuticals, Inc. |
| 8. März 2016 | II | Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin. | Hospira Inc. |
| 2. Juni 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. Mai 2014 | II | Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products. | John W Hollis Inc |
| 13. Sept. 2013 | II | Temperature abuse: Certain vials of Ifosfamide IV products were not refrigerated at certain Amerisource Bergen Drug Corp distribution centers. | AmeriSource Bergen |
| 13. Sept. 2013 | II | Temperature abuse: Certain vials of Ifosfamide IV products were not refrigerated at certain Amerisource Bergen Drug Corp distribution centers. | AmeriSource Bergen |
| 28. Mai 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 |
Klasse I = begründete Wahrscheinlichkeit schwerwiegender Schäden · Klasse II = vorübergehend oder reversibel · Klasse III = Schaden unwahrscheinlich.
Registrierungsstatus
Einige Produkte von Baxter Healthcare Company 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.