Fabrikant-profiel
Boehringer Ingelheim Pharmaceuticals, Inc.
Farmaceutisch bedrijf10 producten gevolgd
10
producten gevolgd
271.920
totaal meldingen
14
recalls geregistreerd
61,6%
ernstig algeheel
Producten
10 van 10 getoond
| Product | Goedgekeurd | Meldingen ↓ | Top signaal | Recalls |
|---|---|---|---|---|
| 2004 | 150.254 | verkeerde toedieningsroute van medicijn | 0 | |
| 2014 | 69.331 | Euglycemische diabetische ketoacidose | 7 | |
| 2011 | 20.890 | Blindheid | 2 | |
| — | 10.745 | slaapstoornis door een algemene medische aandoening | 0 | |
| 2013 | 6.549 | EGFR-genmutatie | 0 | |
| — | 4.837 | COPD | 0 | |
| — | 3.303 | Euglycemische diabetische ketoacidose | 0 | |
| — | 2.719 | Euglycemische diabetische ketoacidose | 4 | |
| — | 1.913 | Euglycemische diabetische ketoacidose | 1 | |
| 2005 | 1.379 | cloaca-extrofie | 0 |
Recall-geschiedenis · 16 geregistreerd
| Datum | Klasse | Reden | Bedrijf |
|---|---|---|---|
| 9 mrt 2023 | II | Labeling: Label Mix-up | Boehringer Ingelheim Pharmaceuticals, Inc. |
| 26 jan 2022 | II | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | CARDINAL HEALTHCARE |
| 15 mrt 2021 | II | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. |
| 15 mrt 2021 | II | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. |
| 15 mrt 2021 | II | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. |
| 15 mrt 2021 | II | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. |
| 15 mrt 2021 | II | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. |
| 5 okt 2020 | II | An extraneous peak was observed for dissolution testing. | Boehringer Ingelheim Pharmaceuticals, Inc. |
| 5 okt 2020 | II | An extraneous peak was observed for dissolution testing. | Boehringer Ingelheim Pharmaceuticals, Inc. |
| 5 okt 2020 | II | An extraneous peak was observed for dissolution testing. | Boehringer Ingelheim Pharmaceuticals, Inc. |
| 7 mrt 2019 | III | Failed Tablet/Capsule Specifications: identification of low weight tablets during routine stability testing. | Boehringer Ingelheim Pharmaceuticals, Inc. |
| 22 okt 2018 | II | Failed Dissolution Specifications: OOS resultsduring routine stability testing | Boehringer Ingelheim Pharmaceuticals, Inc. |
| 4 sep 2018 | II | Cross Contamination With Other Products: | Boehringer Ingelheim Pharmaceuticals, Inc. |
| 22 sep 2017 | III | Labeling: Incorrect or missing package insert. One lot of Mobic Tablets is packaged with an incorrect insert. | Boehringer Ingelheim Pharmaceuticals, Inc. |
| 6 okt 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 okt 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. |
Class I = redelijke kans op ernstige schade · Class II = tijdelijk of omkeerbaar · Class III = onwaarschijnlijk schadelijk.
Registratiestatus
Sommige producten van Boehringer Ingelheim 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.