ANI Pharmaceuticals, Inc.

Compañía farmacéutica4 productos registrados

productos registrados

56.665

notificaciones totales

retiradas registradas

76,9%

graves en total

Productos

mostrando 4 de 4

Producto	Aprobado	Notificaciones ↓	Señal principal	Retiradas
isosorbide mononitrate —	1991	20.266	Angina de pecho	3
ketoconazole —	1997	16.862	Enfermedad renal crónica	10
pyridostigmine bromide —	1955	10.329	Crisis de miastenia gravis	4
pyrazinamide —	1971	9208	síndrome inflamatorio de reconstitución inmune asociado a tuberculosis	3

Historial de retiradas · 29 registradas

Fecha	Clase	Motivo	Empresa
2 jun 2026	III	Presence of foreign substance	ANI Pharmaceuticals, Inc.
1 may 2023	II	CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.	RemedyRepack Inc.
16 sept 2022	III	Failed Viscosity specification: Slightly higher OOS results obtained for viscosity	ALMIRALL, LLC
13 abr 2022	II	cGMP deviations: Temperature abuse	Mckesson Medical-Surgical Inc. Corporate Office
15 feb 2022	II	cGMP Deviations	ANI Pharmaceuticals, Inc.
15 feb 2022	II	cGMP Deviations	ANI Pharmaceuticals, Inc.
15 feb 2022	II	cGMP Deviations	ANI Pharmaceuticals, Inc.
15 feb 2022	II	cGMP Deviations	ANI Pharmaceuticals, Inc.
15 feb 2022	II	cGMP Deviations	ANI Pharmaceuticals, Inc.
9 oct 2020	III	Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.	ANI Pharmaceuticals, Inc.
9 oct 2020	III	Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.	ANI Pharmaceuticals, Inc.
9 oct 2020	III	Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.	ANI Pharmaceuticals, Inc.
9 oct 2020	III	Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.	ANI Pharmaceuticals, Inc.
9 oct 2020	III	Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.	ANI Pharmaceuticals, Inc.
9 oct 2020	III	Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.	ANI Pharmaceuticals, Inc.
9 feb 2018	II	CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.	American Pharmaceutical Ingredients LLC
10 feb 2017	II	Lack of Assurance of Sterility: There are also CGMP Deviations.	Synergy Rx
10 feb 2017	II	Lack of Assurance of Sterility: There are also CGMP Deviations.	Synergy Rx
14 nov 2014	II	Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.	Attix Pharmaceuticals
14 nov 2014	II	Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.	Attix Pharmaceuticals
14 nov 2014	II	Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.	Attix Pharmaceuticals
13 dic 2013	II	Failed Dissolution Specification: Corepharma Inc. is recalling Pyridostigmine Bromide Tablets USP 60 mg due to an out of specification dissolution test generated at the 30 month stability time point.	Corepharma LLC
18 nov 2013	III	Failed Impurities/Degradation Specifications: Out-of-Specification degradant results.	Fougera Pharmaceuticals Inc.
23 sept 2013	III	Subpotent	Tolmar, Inc.
2 jul 2013	II	Labeling:Label Mixup; ISOSORBIDE MONONITRATE Tablet, 20 mg may be potentially mislabeled as COLCHICINE, Tablet, 0.6 mg, NDC 64764011907, Pedigree: AD52778_22, EXP: 5/20/2014; LOSARTAN POTASSIUM, Tablet, 25 mg, NDC 16714058102, Pedigree: AD67989_7, EXP: 5/28/2014; SODIUM CHLORIDE, Tablet, 1 mg, NDC 00223176001, Pedigree: W002611, EXP: 6/4/2014.	Aidapak Services, LLC
2 jul 2013	II	Labeling:Label Mixup; ISOSORBIDE MONONITRATE ER Tablet, 30 mg may be potentially mislabeled as LOSARTAN POTASSIUM, Tablet, 25 mg, NDC 16714058102, Pedigree: W003899, EXP: 6/27/2014; MISOPROSTOL, Tablet, 100 mcg, NDC 43386016012, Pedigree: AD42611_7, EXP: 5/14/2014; hydrOXYzine PAMOATE, Capsule, 100 mg, NDC 00555032402, Pedigree: W003332, EXP: 6/18/2014; glyBURIDE, Tablet, 2.5 mg, NDC 0009383	Aidapak Services, LLC
2 jul 2013	II	Labeling:Label Mixup; ISOSORBIDE MONONITRATE Tablet, 10 mg may be potentially mislabeled as ASCORBIC ACID, Tablet, 250 mg, NDC 00904052260, Pedigree: AD28322_10, EXP: 5/6/2014.	Aidapak Services, LLC
2 jul 2013	II	Failed Stability Specifications: Pyridostigmine Bromide tablets, is being recalled due to an out of specification test result during stablity testing.	Core Pharma Llc
18 jul 2012	III	Failed Impurities/Degradation Specifications: Ketoconazole Cream 2% is the subject of a voluntary drug recall by Fougera due to an Out Of Specification result for an unknown degradant product	Fougera 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 ANI 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.