Profil du fabricant
Advagen Pharma Ltd.
Société pharmaceutique3 produits suivis
3
produits suivis
255 687
total des notifications
128
rappels enregistrés
56,5%
graves au total
Produits
affichage de 3 sur 3
| Produit | Approuvé | Notifications ↓ | Signal principal | Rappels |
|---|---|---|---|---|
| 1990 | 189 078 | Asthme | 19 | |
| — | 37 381 | Asthme | 100 | |
| — | 29 228 | Asthme | 9 |
Historique des rappels · 50 enregistrés
| Date | Classe | Motif | Fabricant |
|---|---|---|---|
| 8 avr. 2026 | II | Defective container: defect in a batch of bottle caps, specifically involving dislodged or missing cap liners. | Apotex Corp. |
| 12 déc. 2025 | I | Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter. | Medinatura New Mexico, inc. |
| 12 déc. 2025 | I | Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter. | Medinatura New Mexico, inc. |
| 14 févr. 2024 | II | CGMP Deviations:Suspected potential presence of Burkholderia cepacia complex | Golden State Medical Supply Inc. |
| 9 févr. 2024 | II | CGMP Deviations: potential presence of Burkholderia cepacia complex | Apotex Corp. |
| 28 déc. 2023 | II | CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products. | Seaway Pharma Inc. |
| 28 déc. 2023 | II | CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products. | Seaway Pharma Inc. |
| 26 avr. 2023 | II | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. |
| 23 févr. 2023 | II | CGMP Deviations: Raw material recalled by repackager, due to discoloration. | Nutraceutical Corporation |
| 23 févr. 2023 | II | CGMP Deviations: Raw material recalled by repackager, due to discoloration. | Nutraceutical Corporation |
| 13 juin 2022 | II | Defective container: defect prevents product from dispensing as intended. | Akorn, Inc. |
| 26 janv. 2022 | II | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | CARDINAL HEALTHCARE |
| 26 janv. 2022 | II | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | CARDINAL HEALTHCARE |
| 26 janv. 2022 | II | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | CARDINAL HEALTHCARE |
| 24 janv. 2022 | II | cGMP deviations | Ultra Seal Corporation |
| 26 oct. 2021 | II | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. | Perrigo Company PLC |
| 26 oct. 2021 | II | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. | Perrigo Company PLC |
| 26 oct. 2021 | II | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. | Perrigo Company PLC |
| 26 oct. 2021 | II | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. | Perrigo Company PLC |
| 26 oct. 2021 | II | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. | Perrigo Company PLC |
| 26 oct. 2021 | II | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. | Perrigo Company PLC |
| 26 oct. 2021 | II | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. | Perrigo Company PLC |
| 22 sept. 2021 | II | Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol | Teva Pharmaceuticals USA |
| 22 sept. 2021 | II | Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol | Teva Pharmaceuticals USA |
| 22 sept. 2021 | II | Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol | Teva Pharmaceuticals USA |
| 22 sept. 2021 | II | Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol | Teva Pharmaceuticals USA |
| 22 sept. 2021 | II | Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol | Teva Pharmaceuticals USA |
| 15 mars 2021 | II | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. |
| 21 mai 2019 | II | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). | Torrent Pharma Inc |
| 21 mai 2019 | II | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). | Torrent Pharma Inc |
| 3 août 2018 | II | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC |
| 3 août 2018 | II | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC |
| 3 août 2018 | II | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC |
| 3 août 2018 | II | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC |
| 3 août 2018 | II | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC |
| 3 août 2018 | I | Microbial Contamination of Non-Sterile Products: Failed microbiological testing for Pseudomonas aeruginosa. | Product Quest Manufacturing LLC |
| 31 mai 2018 | II | Presence of foreign substance: glass particles | Apotex Inc. |
| 9 févr. 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 |
| 5 juil. 2016 | II | Marketed Without An Approved NDA/ANDA: product is an unapproved drug due to nasal decongestant claims as well as not complying with the nasal decongestant final monograph. | Let's Talk Health, Inc. |
| 27 févr. 2015 | II | Failed Stability Specifications: Out of specification for preservative, benazalkonium chloride. | Akorn, 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 |
| 30 janv. 2013 | II | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | TG United, Inc. |
| 30 janv. 2013 | II | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | TG United, Inc. |
| 30 janv. 2013 | II | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | TG United, Inc. |
| 30 janv. 2013 | II | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | TG United, Inc. |
| 30 janv. 2013 | II | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | TG United, Inc. |
| 30 janv. 2013 | II | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | TG United, Inc. |
| 30 janv. 2013 | II | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | TG United, Inc. |
| 30 janv. 2013 | II | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | TG United, Inc. |
| 18 déc. 2012 | I | Microbial Contamination of Non-Sterile Products: Product may be contaminated with Burkholderia cepacia. | Matrixx Initiatives Inc |
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 Advagen Pharma Ltd. 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.