AvPAK

Farmaceutisch bedrijf2 producten gevolgd

producten gevolgd

22.105

totaal meldingen

recalls geregistreerd

63,2%

ernstig algeheel

Producten

2 van 2 getoond

Product	Goedgekeurd	Meldingen ↓	Top signaal	Recalls
isosorbide dinitrate —	1968	19.613	TIA (transient ischemisch attack)	8
artificial tears —	—	2.492	endocriene oftalmopathie	20

Recall-geschiedenis · 26 geregistreerd

Datum	Klasse	Reden	Bedrijf
25 mrt 2026	II	Lack of Assurance of Sterility	Preferred Pharmaceuticals, Inc.
3 mrt 2026	II	Lack of Assurance of Sterility	K.C. Pharmaceuticals, Inc
3 mrt 2026	II	Lack of Assurance of Sterility	K.C. Pharmaceuticals, Inc
23 apr 2025	II	cGMP deviations and lack of assurance of sterility.	BRS Analytical Services, LLC
13 jun 2023	II	CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill line.	K.C. Pharmaceuticals, Inc
26 apr 2023	II	CGMP Deviations: Firm went out of business and could no longer continue stability studies.	Akorn, Inc.
30 jan 2023	I	Non-Sterility: FDA analysis found unopened products to have bacterial contamination.	Global Pharma Healthcare Private Limited
30 jan 2023	I	Non-Sterility: FDA analysis found unopened products to have bacterial contamination.	Global Pharma Healthcare Private Limited
30 jan 2023	II	CGMP Deviations: All other lots of eye drops are being recalled due to CGMP Deviations because they were manufactured in the same facility under the same conditions as the lots found to be contaminated.	Global Pharma Healthcare Private Limited
30 jan 2023	II	CGMP Deviations: All other lots of eye drops are being recalled due to CGMP Deviations because they were manufactured in the same facility under the same conditions as the lots found to be contaminated.	Global Pharma Healthcare Private Limited
13 okt 2022	II	CGMP Deviations:	Akorn, Inc.
13 okt 2022	II	CGMP Deviations:	Akorn, Inc.
2 aug 2021	II	Non-Sterility - OOS sterility testing observed during 12-month controlled room temperature stability testing. The microbiological investigation identified the organism as a member of the Bacillus cereus group.	Akorn, Inc.
2 nov 2018	II	Cross Contamination with Other Products	Sandoz Inc
2 nov 2018	II	Cross Contamination with Other Products	Sandoz Inc
2 nov 2018	II	Cross Contamination with Other Products	Sandoz Inc
2 nov 2018	II	Cross Contamination with Other Products	Sandoz Inc
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
2 jul 2013	II	Labeling:Label Mixup; ISOSORBIDE DINITRATE ER Tablet, 40 mg may be potentially mislabeled as CILOSTAZOL, Tablet, 50 mg, NDC 60505252101, Pedigree: AD21811_7, EXP: 5/1/2014.	Aidapak Services, LLC
2 jul 2013	II	Labeling: Label Mixup: ISOSORBIDE DINITRATE, Tablet, 5 mg may have potentially been mislabeled as one of the following drugs: CILOSTAZOL, Tablet, 100 mg, NDC 00054004421, Pedigree: W003470, EXP: 6/20/2014; PERPHENAZINE, Tablet, 8 mg, NDC 00630506221, Pedigree: AD54605_1, EXP: 4/30/2014.	Aidapak Services, LLC
2 jul 2013	II	Labeling: Label Mixup: ISOSORBIDE DINITRATE, Tablet, 10 mg may have potentially been mislabeled as one of the following drugs: SODIUM CHLORIDE, Tablet, 1 mg, NDC 00223176001, Pedigree: AD22845_10, EXP: 5/2/2014; CALCITRIOL, Capsule, 0.5 mcg, NDC 63304024001, Pedigree: AD32757_10, EXP: 5/14/2014.	Aidapak Services, LLC
25 mei 2012	II	Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.	Franck's Lab Inc., d.b.a. Franck's Compounding Lab
25 mei 2012	II	Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.	Franck's Lab Inc., d.b.a. Franck's Compounding Lab
25 mei 2012	II	Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.	Franck's Lab Inc., d.b.a. Franck's Compounding Lab
25 mei 2012	II	Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.	Franck's Lab Inc., d.b.a. Franck's Compounding Lab
25 mei 2012	II	Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.	Franck's Lab Inc., d.b.a. Franck's Compounding Lab

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Registratiestatus

Sommige producten van AvPAK 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.