Profil du fabricant
Boehringer Ingelheim Pharmaceuticals, Inc.
Société pharmaceutique10 produits suivis
10
produits suivis
271 920
total des notifications
14
rappels enregistrés
61,6%
graves au total
Produits
affichage de 10 sur 10
| Produit | Approuvé | Notifications ↓ | Signal principal | Rappels |
|---|---|---|---|---|
| 2004 | 150 254 | voie d'administration du médicament incorrecte | 0 | |
| 2014 | 69 331 | Acidocétose diabétique euglycémique | 7 | |
| 2011 | 20 890 | Cécité | 2 | |
| — | 10 745 | trouble du sommeil dû à une condition médicale générale | 0 | |
| 2013 | 6 549 | Mutation du gène EGFR | 0 | |
| — | 4 837 | Bronchopneumopathie chronique obstructive | 0 | |
| — | 3 303 | Acidocétose diabétique euglycémique | 0 | |
| — | 2 719 | Acidocétose diabétique euglycémique | 4 | |
| — | 1 913 | Acidocétose diabétique euglycémique | 1 | |
| 2005 | 1 379 | Extrophie cloacale | 0 |
Historique des rappels · 16 enregistrés
| Date | Classe | Motif | Fabricant |
|---|---|---|---|
| 9 mars 2023 | II | Labeling: Label Mix-up | Boehringer Ingelheim Pharmaceuticals, Inc. |
| 26 janv. 2022 | II | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | CARDINAL HEALTHCARE |
| 15 mars 2021 | II | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. |
| 15 mars 2021 | II | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. |
| 15 mars 2021 | II | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. |
| 15 mars 2021 | II | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. |
| 15 mars 2021 | II | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. |
| 5 oct. 2020 | II | An extraneous peak was observed for dissolution testing. | Boehringer Ingelheim Pharmaceuticals, Inc. |
| 5 oct. 2020 | II | An extraneous peak was observed for dissolution testing. | Boehringer Ingelheim Pharmaceuticals, Inc. |
| 5 oct. 2020 | II | An extraneous peak was observed for dissolution testing. | Boehringer Ingelheim Pharmaceuticals, Inc. |
| 7 mars 2019 | III | Failed Tablet/Capsule Specifications: identification of low weight tablets during routine stability testing. | Boehringer Ingelheim Pharmaceuticals, Inc. |
| 22 oct. 2018 | II | Failed Dissolution Specifications: OOS resultsduring routine stability testing | Boehringer Ingelheim Pharmaceuticals, Inc. |
| 4 sept. 2018 | II | Cross Contamination With Other Products: | Boehringer Ingelheim Pharmaceuticals, Inc. |
| 22 sept. 2017 | III | Labeling: Incorrect or missing package insert. One lot of Mobic Tablets is packaged with an incorrect insert. | Boehringer Ingelheim Pharmaceuticals, Inc. |
| 6 oct. 2016 | II | Presence of foreign tablets/capsules: 50 mg Persantine tablets were found in a 75 mg Persantine 100-count bottle and 50 mg Persantine tablet was found in a 100 count bottle of 75 mg Dipyridamole. | Boehringer Ingelheim Pharmaceuticals, Inc. |
| 6 oct. 2016 | II | Presence of foreign tablets/capsules: 50 mg Persantine tablets were found in a 75 mg Persantine 100-count bottle and 50 mg Persantine tablet was found in a 100 count bottle of 75 mg Dipyridamole. | Boehringer Ingelheim 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 Boehringer Ingelheim 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.