Herstellerprofil
BluePoint Laboratories
Pharmaunternehmen4 erfasste Produkte
4
erfasste Produkte
122.013
Meldungen insgesamt
13
dokumentierte Rückrufe
79,9%
schwerwiegend insgesamt
Produkte
4 von 4 angezeigt
| Produkt | Zugelassen | Meldungen ↓ | Top-Signal | Rückrufe |
|---|---|---|---|---|
| 1983 | 73.031 | Fieberhafte Neutropenie | 5 | |
| 2006 | 36.591 | Pleuraerguss | 1 | |
| 1979 | 7.461 | Vaginale Blähungen | 4 | |
| 2006 | 4.930 | Wiederkehrende akute myeloische Leukämie | 3 |
Rückrufhistorie · 11 dokumentiert
| Datum | Klasse | Grund | Firma |
|---|---|---|---|
| 2. Juli 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. März 2021 | II | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. |
| 15. März 2021 | II | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. |
| 10. Feb. 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. Juni 2019 | II | Lack of Assurance of Sterility | Infusion Options, Inc. |
| 12. Juni 2019 | II | Lack of Assurance of Sterility | Infusion Options, Inc. |
| 5. März 2018 | III | Failed impurities/degradation specifications: Failure to water content and impurity | InvaGen Pharmaceuticals, Inc. |
| 22. Dez. 2016 | II | Failed dissolution specification: recalled due to an out of specification dissolution result of 40% (Specification: NLT 80%) | Sandoz Incorporated |
| 12. Feb. 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 |
Klasse I = begründete Wahrscheinlichkeit schwerwiegender Schäden · Klasse II = vorübergehend oder reversibel · Klasse III = Schaden unwahrscheinlich.
Registrierungsstatus
Einige Produkte von BluePoint Laboratories sind nicht für die Anwendung am Menschen FDA-registriert. Für nicht registrierte Substanzen (Peptide, SARMs ohne Humanzulassung) existiert kein legitimer Anbieter für die Anwendung am Menschen. Das Fehlen eines Bezugswegs ist die Sicherheitsinformation.