Boehringer Ingelheim Pharmaceuticals, Inc.

Compañía farmacéutica10 productos registrados

productos registrados

271.920

notificaciones totales

retiradas registradas

61,6%

graves en total

Productos

mostrando 10 de 10

Producto	Aprobado	Notificaciones ↓	Señal principal	Retiradas
tiotropium bromide —	2004	150.254	vía de administración del fármaco incorrecta	0
empagliflozin —	2014	69.331	Cetoacidosis diabética euglucémica	7
linagliptin —	2011	20.890	Ceguera	2
tiotropium bromide inhalation spray —	—	10.745	trastorno del sueño debido a una afección médica general	0
afatinib —	2013	6549	Mutación del gen EGFR	0
tiotropium bromide and olodaterol —	—	4837	Enfermedad pulmonar obstructiva crónica	0
empagliflozin, metformin hydrochloride —	—	3303	Cetoacidosis diabética euglucémica	0
empagliflozin and metformin hydrochloride —	—	2719	Cetoacidosis diabética euglucémica	4
empagliflozin and linagliptin —	—	1913	Cetoacidosis diabética euglucémica	1
tipranavir —	2005	1379	Extrofia cloacal	0

Historial de retiradas · 16 registradas

Fecha	Clase	Motivo	Empresa
9 mar 2023	II	Labeling: Label Mix-up	Boehringer Ingelheim Pharmaceuticals, Inc.
26 ene 2022	II	CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.	CARDINAL HEALTHCARE
15 mar 2021	II	CGMP Deviations: Intermittent exposure to temperature excursion during storage.	Cardinal Health Inc.
15 mar 2021	II	CGMP Deviations: Intermittent exposure to temperature excursion during storage.	Cardinal Health Inc.
15 mar 2021	II	CGMP Deviations: Intermittent exposure to temperature excursion during storage.	Cardinal Health Inc.
15 mar 2021	II	CGMP Deviations: Intermittent exposure to temperature excursion during storage.	Cardinal Health Inc.
15 mar 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 mar 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.

Clase I = probabilidad razonable de daño grave · Clase II = temporal o reversible · Clase III = improbable que cause daño.

Estado de registro

Algunos productos de Boehringer Ingelheim Pharmaceuticals, Inc. no están registrados por la FDA para uso humano. Para las sustancias no registradas (péptidos, SARM sin registro humano) no existe ningún proveedor legítimo para uso humano. La ausencia de una vía de aprovisionamiento es la información de seguridad.