Profil du fabricant
BluePoint Laboratories
Société pharmaceutique4 produits suivis
4
produits suivis
122 013
total des notifications
13
rappels enregistrés
79,9%
graves au total
Produits
affichage de 4 sur 4
| Produit | Approuvé | Notifications ↓ | Signal principal | Rappels |
|---|---|---|---|---|
| 1983 | 73 031 | Neutropénie fébrile | 5 | |
| 2006 | 36 591 | Épanchement pleural | 1 | |
| 1979 | 7 461 | Flatulence vaginale | 4 | |
| 2006 | 4 930 | Leucémie myéloïde aiguë récurrente | 3 |
Historique des rappels · 11 enregistrés
| Date | Classe | Motif | Fabricant |
|---|---|---|---|
| 2 juil. 2024 | II | CGMP Deviations: Out of Specification for Total Aerobic Microbial Count (TAMC) test for unfiltered bulk for decitabine for injection. | SUN PHARMACEUTICAL INDUSTRIES INC |
| 15 mars 2021 | II | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. |
| 15 mars 2021 | II | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. |
| 10 févr. 2021 | II | Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products. | Teva Pharmaceuticals USA |
| 12 juin 2019 | II | Lack of Assurance of Sterility | Infusion Options, Inc. |
| 12 juin 2019 | II | Lack of Assurance of Sterility | Infusion Options, Inc. |
| 5 mars 2018 | III | Failed impurities/degradation specifications: Failure to water content and impurity | InvaGen Pharmaceuticals, Inc. |
| 22 déc. 2016 | II | Failed dissolution specification: recalled due to an out of specification dissolution result of 40% (Specification: NLT 80%) | Sandoz Incorporated |
| 12 févr. 2015 | II | Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance. | Health Innovations Pharmacy, 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 |
| 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 |
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 BluePoint Laboratories 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.