Herstellerprofil
Bayer HealthCare Pharmaceuticals Inc.
Pharmaunternehmen8 erfasste Produkte
8
erfasste Produkte
173.295
Meldungen insgesamt
9
dokumentierte Rückrufe
77,4%
schwerwiegend insgesamt
Produkte
8 von 8 angezeigt
| Produkt | Zugelassen | Meldungen ↓ | Top-Signal | Rückrufe |
|---|---|---|---|---|
| 2005 | 51.767 | Gallenblasenverletzung | 6 | |
| — | 45.168 | Gallenblasenverletzung | 3 | |
| 2013 | 31.875 | Pulmonale arterielle Hypertonie | 0 | |
| 1993 | 19.028 | Multiple Sklerose | 0 | |
| 2012 | 11.442 | Metastasierter Darmkrebs | 0 | |
| 2019 | 5.120 | Hormonresistenter Prostatakrebs | 0 | |
| 2013 | 4.976 | Hormonresistenter Prostatakrebs | 0 | |
| 1995 | 3.919 | Kontrastmittel-Enzephalopathie | 0 |
Rückrufhistorie · 16 dokumentiert
| Datum | Klasse | Grund | Firma |
|---|---|---|---|
| 19. Nov. 2021 | III | Subpotent Drug | Lupin Pharmaceuticals Inc. |
| 1. Okt. 2021 | I | Chemical Contamination: presence of benzene | Bayer Healthcare Pharmaceuticals Inc. |
| 1. Okt. 2021 | I | Chemical Contamination: presence of benzene | Bayer Healthcare Pharmaceuticals Inc. |
| 1. Okt. 2021 | II | cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene. | Bayer Healthcare Pharmaceuticals Inc. |
| 1. Okt. 2021 | II | cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene. | Bayer Healthcare Pharmaceuticals Inc. |
| 1. Okt. 2021 | I | Chemical Contamination: presence of benzene | Bayer Healthcare Pharmaceuticals Inc. |
| 1. Okt. 2021 | II | cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene. | Bayer Healthcare Pharmaceuticals Inc. |
| 1. Okt. 2021 | II | cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene. | Bayer Healthcare Pharmaceuticals Inc. |
| 1. Okt. 2021 | II | cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene. | Bayer Healthcare Pharmaceuticals Inc. |
| 1. Okt. 2021 | I | Chemical Contamination: presence of benzene | Bayer Healthcare Pharmaceuticals Inc. |
| 9. Juli 2019 | I | Failed dissolution specifications : failed results at the 3-month stability time point. | Jubilant Cadista Pharmaceuticals, Inc. |
| 1. März 2019 | II | Contraceptive Tablets Out of Sequence: Missing or incorrect tablet placement. | Apotex Inc. |
| 13. Juni 2013 | III | Failed Stability Specifications: Out of specification results for particle size were obtained at the 60 month test point. | Bayer HealthCare Pharmaceuticals Inc. |
| 13. Feb. 2013 | II | Failed Tablet/Capsule Specification; tablet breakage while pushing through the blister pack (dispenser) . | Watson Laboratories Inc |
| 22. Jan. 2013 | III | Tablet/Capsule Imprinted with Wrong ID; a portion of the tablets could contain the incorrect debossing on one side of the tablet U2 instead of U3. | Sandoz Incorporated |
| 8. Mai 2012 | II | Cross Contamination w/Other Products: This active pharmaceutical ingredient is being recalled due to cross contamination with another product. | Bayer HealthCare Pharmaceuticals Inc. |
Klasse I = begründete Wahrscheinlichkeit schwerwiegender Schäden · Klasse II = vorübergehend oder reversibel · Klasse III = Schaden unwahrscheinlich.
Registrierungsstatus
Einige Produkte von Bayer HealthCare Pharmaceuticals 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.