HealthProves
Home/Fabrikanten/ANI Pharmaceuticals, Inc.
Fabrikant-profiel

ANI Pharmaceuticals, Inc.

Farmaceutisch bedrijf4 producten gevolgd
4
producten gevolgd
56.665
totaal meldingen
20
recalls geregistreerd
76,9%
ernstig algeheel
Producten
4 van 4 getoond
ProductGoedgekeurdMeldingen ↓Top signaalRecalls
199120.266angina pectoris3
199716.862chronische nierziekte10
195510.329myasthenia gravis crisis4
19719.208immuunreconstitutie inflammatoir syndroom geassocieerd met tuberculose3
Recall-geschiedenis · 29 geregistreerd
DatumKlasseRedenBedrijf
2 jun 2026IIIPresence of foreign substanceANI Pharmaceuticals, Inc.
1 mei 2023IICGMP 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 sep 2022IIIFailed Viscosity specification: Slightly higher OOS results obtained for viscosityALMIRALL, LLC
13 apr 2022IIcGMP deviations: Temperature abuseMckesson Medical-Surgical Inc. Corporate Office
15 feb 2022IIcGMP DeviationsANI Pharmaceuticals, Inc.
15 feb 2022IIcGMP DeviationsANI Pharmaceuticals, Inc.
15 feb 2022IIcGMP DeviationsANI Pharmaceuticals, Inc.
15 feb 2022IIcGMP DeviationsANI Pharmaceuticals, Inc.
15 feb 2022IIcGMP DeviationsANI Pharmaceuticals, Inc.
9 okt 2020IIILabeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.ANI Pharmaceuticals, Inc.
9 okt 2020IIILabeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.ANI Pharmaceuticals, Inc.
9 okt 2020IIILabeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.ANI Pharmaceuticals, Inc.
9 okt 2020IIILabeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.ANI Pharmaceuticals, Inc.
9 okt 2020IIILabeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.ANI Pharmaceuticals, Inc.
9 okt 2020IIILabeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.ANI Pharmaceuticals, Inc.
9 feb 2018IICGMP 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 2017IILack of Assurance of Sterility: There are also CGMP Deviations.Synergy Rx
10 feb 2017IILack of Assurance of Sterility: There are also CGMP Deviations.Synergy Rx
14 nov 2014IIPenicillin 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 2014IIPenicillin 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 2014IIPenicillin 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 dec 2013IIFailed 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 2013IIIFailed Impurities/Degradation Specifications: Out-of-Specification degradant results.Fougera Pharmaceuticals Inc.
23 sep 2013IIISubpotentTolmar, Inc.
2 jul 2013IILabeling: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 2013IILabeling: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 0009383Aidapak Services, LLC
2 jul 2013IILabeling: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 2013IIFailed Stability Specifications: Pyridostigmine Bromide tablets, is being recalled due to an out of specification test result during stablity testing.Core Pharma Llc
18 jul 2012IIIFailed 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 productFougera Pharmaceuticals Inc.

Class I = redelijke kans op ernstige schade · Class II = tijdelijk of omkeerbaar · Class III = onwaarschijnlijk schadelijk.

Registratiestatus

Sommige producten van ANI 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.