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ANI Pharmaceuticals, Inc.

Pharmaunternehmen4 erfasste Produkte
4
erfasste Produkte
56.665
Meldungen insgesamt
20
dokumentierte Rückrufe
76,9%
schwerwiegend insgesamt
Produkte
4 von 4 angezeigt
ProduktZugelassenMeldungen ↓Top-SignalRückrufe
199120.266Angina Pectoris3
199716.862Chronische Nierenerkrankung10
195510.329Myasthenia gravis Krise4
19719.208Immunsystem-Reaktivierungs-Syndrom bei Tuberkulose3
Rückrufhistorie · 29 dokumentiert
DatumKlasseGrundFirma
2. Juni 2026IIIPresence of foreign substanceANI Pharmaceuticals, Inc.
1. Mai 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. Sept. 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. Dez. 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. Sept. 2013IIISubpotentTolmar, Inc.
2. Juli 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. Juli 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. Juli 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. Juli 2013IIFailed Stability Specifications: Pyridostigmine Bromide tablets, is being recalled due to an out of specification test result during stablity testing.Core Pharma Llc
18. Juli 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.

Klasse I = begründete Wahrscheinlichkeit schwerwiegender Schäden · Klasse II = vorübergehend oder reversibel · Klasse III = Schaden unwahrscheinlich.

Registrierungsstatus

Einige Produkte von ANI 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.