Profil du fabricant
Bayer HealthCare Pharmaceuticals Inc.
Société pharmaceutique8 produits suivis
8
produits suivis
173 295
total des notifications
9
rappels enregistrés
77,4%
graves au total
Produits
affichage de 8 sur 8
| Produit | Approuvé | Notifications ↓ | Signal principal | Rappels |
|---|---|---|---|---|
| 2005 | 51 767 | Lésion de la vésicule biliaire | 6 | |
| — | 45 168 | Lésion de la vésicule biliaire | 3 | |
| 2013 | 31 875 | Hypertension artérielle pulmonaire | 0 | |
| 1993 | 19 028 | Sclérose en plaques | 0 | |
| 2012 | 11 442 | cancer colorectal métastatique | 0 | |
| 2019 | 5 120 | Cancer de la prostate résistant à l'hormonothérapie | 0 | |
| 2013 | 4 976 | Cancer de la prostate résistant à l'hormonothérapie | 0 | |
| 1995 | 3 919 | encéphalopathie au produit de contraste | 0 |
Historique des rappels · 16 enregistrés
| Date | Classe | Motif | Fabricant |
|---|---|---|---|
| 19 nov. 2021 | III | Subpotent Drug | Lupin Pharmaceuticals Inc. |
| 1 oct. 2021 | I | Chemical Contamination: presence of benzene | Bayer Healthcare Pharmaceuticals Inc. |
| 1 oct. 2021 | I | Chemical Contamination: presence of benzene | Bayer Healthcare Pharmaceuticals Inc. |
| 1 oct. 2021 | II | cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene. | Bayer Healthcare Pharmaceuticals Inc. |
| 1 oct. 2021 | II | cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene. | Bayer Healthcare Pharmaceuticals Inc. |
| 1 oct. 2021 | I | Chemical Contamination: presence of benzene | Bayer Healthcare Pharmaceuticals Inc. |
| 1 oct. 2021 | II | cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene. | Bayer Healthcare Pharmaceuticals Inc. |
| 1 oct. 2021 | II | cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene. | Bayer Healthcare Pharmaceuticals Inc. |
| 1 oct. 2021 | II | cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene. | Bayer Healthcare Pharmaceuticals Inc. |
| 1 oct. 2021 | I | Chemical Contamination: presence of benzene | Bayer Healthcare Pharmaceuticals Inc. |
| 9 juil. 2019 | I | Failed dissolution specifications : failed results at the 3-month stability time point. | Jubilant Cadista Pharmaceuticals, Inc. |
| 1 mars 2019 | II | Contraceptive Tablets Out of Sequence: Missing or incorrect tablet placement. | Apotex Inc. |
| 13 juin 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 févr. 2013 | II | Failed Tablet/Capsule Specification; tablet breakage while pushing through the blister pack (dispenser) . | Watson Laboratories Inc |
| 22 janv. 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. |
Classe I = probabilité raisonnable de préjudice grave · Classe II = temporaire ou réversible · Classe III = peu susceptible de causer un préjudice.
Statut d'enregistrement
Certains produits de Bayer HealthCare Pharmaceuticals Inc. ne sont pas enregistrés auprès de la FDA pour un usage humain. Pour les substances non enregistrées (peptides, SARMs sans enregistrement humain), aucun fournisseur légitime à usage humain n'existe. L'absence de filière d'approvisionnement est l'information de sécurité.