AvPAK

Société pharmaceutique2 produits suivis

produits suivis

22 105

total des notifications

rappels enregistrés

63,2%

graves au total

Produits

affichage de 2 sur 2

Produit	Approuvé	Notifications ↓	Signal principal	Rappels
isosorbide dinitrate —	1968	19 613	Accident ischémique transitoire	8
artificial tears —	—	2 492	Ophtalmopathie endocrinienne	20

Historique des rappels · 26 enregistrés

Date	Classe	Motif	Fabricant
25 mars 2026	II	Lack of Assurance of Sterility	Preferred Pharmaceuticals, Inc.
3 mars 2026	II	Lack of Assurance of Sterility	K.C. Pharmaceuticals, Inc
3 mars 2026	II	Lack of Assurance of Sterility	K.C. Pharmaceuticals, Inc
23 avr. 2025	II	cGMP deviations and lack of assurance of sterility.	BRS Analytical Services, LLC
13 juin 2023	II	CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill line.	K.C. Pharmaceuticals, Inc
26 avr. 2023	II	CGMP Deviations: Firm went out of business and could no longer continue stability studies.	Akorn, Inc.
30 janv. 2023	I	Non-Sterility: FDA analysis found unopened products to have bacterial contamination.	Global Pharma Healthcare Private Limited
30 janv. 2023	I	Non-Sterility: FDA analysis found unopened products to have bacterial contamination.	Global Pharma Healthcare Private Limited
30 janv. 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 janv. 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 oct. 2022	II	CGMP Deviations:	Akorn, Inc.
13 oct. 2022	II	CGMP Deviations:	Akorn, Inc.
2 août 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 juil. 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 juil. 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 juil. 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 mai 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 mai 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 mai 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 mai 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 mai 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

Classe I = probabilité raisonnable de préjudice grave · Classe II = temporaire ou réversible · Classe III = peu susceptible de causer un préjudice.

Statut d'enregistrement

Certains produits de AvPAK ne sont pas enregistrés auprès de la FDA pour un usage humain. Pour les substances non enregistrées (peptides, SARMs sans enregistrement humain), aucun fournisseur légitime à usage humain n'existe. L'absence de filière d'approvisionnement est l'information de sécurité.