Fabrikant-profiel
Bayer HealthCare Pharmaceuticals Inc.
Farmaceutisch bedrijf8 producten gevolgd
8
producten gevolgd
173.295
totaal meldingen
9
recalls geregistreerd
77,4%
ernstig algeheel
Producten
8 van 8 getoond
| Product | Goedgekeurd | Meldingen ↓ | Top signaal | Recalls |
|---|---|---|---|---|
| 2005 | 51.767 | beschadiging van de galblaas | 6 | |
| — | 45.168 | beschadiging van de galblaas | 3 | |
| 2013 | 31.875 | Pulmonale arteriële hypertensie | 0 | |
| 1993 | 19.028 | Multiple sclerose | 0 | |
| 2012 | 11.442 | Gemetastaseerde colorectale kanker | 0 | |
| 2019 | 5.120 | hormoonongevoelige prostaatkanker | 0 | |
| 2013 | 4.976 | hormoonongevoelige prostaatkanker | 0 | |
| 1995 | 3.919 | contrastencefalopathie | 0 |
Recall-geschiedenis · 16 geregistreerd
| Datum | Klasse | Reden | Bedrijf |
|---|---|---|---|
| 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 jul 2019 | I | Failed dissolution specifications : failed results at the 3-month stability time point. | Jubilant Cadista Pharmaceuticals, Inc. |
| 1 mrt 2019 | II | Contraceptive Tablets Out of Sequence: Missing or incorrect tablet placement. | Apotex Inc. |
| 13 jun 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 mei 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. |
Class I = redelijke kans op ernstige schade · Class II = tijdelijk of omkeerbaar · Class III = onwaarschijnlijk schadelijk.
Registratiestatus
Sommige producten van Bayer HealthCare Pharmaceuticals 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.