Herstellerprofil
Boehringer Ingelheim Pharmaceuticals, Inc.
Pharmaunternehmen10 erfasste Produkte
10
erfasste Produkte
271.920
Meldungen insgesamt
14
dokumentierte Rückrufe
61,6%
schwerwiegend insgesamt
Produkte
10 von 10 angezeigt
| Produkt | Zugelassen | Meldungen ↓ | Top-Signal | Rückrufe |
|---|---|---|---|---|
| 2004 | 150.254 | Falscher Verabreichungsweg des Medikaments | 0 | |
| 2014 | 69.331 | Euglykäämische diabetische Ketoazidose | 7 | |
| 2011 | 20.890 | Erblindung | 2 | |
| — | 10.745 | Schlafstörung wegen einer allgemeinen Erkrankung | 0 | |
| 2013 | 6.549 | EGFR-Genmutation | 0 | |
| — | 4.837 | Chronisch obstruktive Lungenerkrankung | 0 | |
| — | 3.303 | Euglykäämische diabetische Ketoazidose | 0 | |
| — | 2.719 | Euglykäämische diabetische Ketoazidose | 4 | |
| — | 1.913 | Euglykäämische diabetische Ketoazidose | 1 | |
| 2005 | 1.379 | Kloakenextrophie | 0 |
Rückrufhistorie · 16 dokumentiert
| Datum | Klasse | Grund | Firma |
|---|---|---|---|
| 9. März 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. März 2021 | II | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. |
| 15. März 2021 | II | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. |
| 15. März 2021 | II | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. |
| 15. März 2021 | II | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. |
| 15. März 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. März 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. 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. 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. |
Klasse I = begründete Wahrscheinlichkeit schwerwiegender Schäden · Klasse II = vorübergehend oder reversibel · Klasse III = Schaden unwahrscheinlich.
Registrierungsstatus
Einige Produkte von Boehringer Ingelheim 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.