Profil du fabricant
Actavis Pharma, Inc.
Société pharmaceutique2 produits suivis
2
produits suivis
39 164
total des notifications
12
rappels enregistrés
87,6%
graves au total
Produits
affichage de 2 sur 2
| Produit | Approuvé | Notifications ↓ | Signal principal | Rappels |
|---|---|---|---|---|
| 1988 | 37 667 | Encéphalopathie hépatique | 9 | |
| 1988 | 1 497 | Hypersécrétion acide de rebond | 3 |
Historique des rappels · 11 enregistrés
| Date | Classe | Motif | Fabricant |
|---|---|---|---|
| 26 avr. 2023 | II | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. |
| 26 avr. 2023 | II | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. |
| 7 janv. 2020 | II | CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the API Nizatidine. | Mylan Pharmaceuticals Inc. |
| 7 janv. 2020 | II | CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the API Nizatidine. | Mylan Pharmaceuticals 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 |
| 26 juin 2017 | II | Microbial contamination of non-sterile product: product failed Total Yeast/Mold Count specification. | VistaPharm, Inc. |
| 26 juin 2017 | II | Microbial contamination of non-sterile product: product failed Total Yeast/Mold Count specification. | VistaPharm, Inc. |
| 18 janv. 2017 | II | CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia. | VistaPharm, Inc. |
| 18 janv. 2017 | II | CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia. | VistaPharm, Inc. |
| 9 nov. 2016 | II | Microbial Contamination of Non-Sterile Products: bulk solution tested positive for the presence of the bacteria, Burkholderia cepacia. | VistaPharm, 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 Actavis Pharma, Inc. 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.