Herstellerprofil
Blue Echo Care LLC
Pharmaunternehmen2 erfasste Produkte
2
erfasste Produkte
1.439.995
Meldungen insgesamt
14
dokumentierte Rückrufe
18,2%
schwerwiegend insgesamt
Produkte
Rückrufhistorie · 11 dokumentiert
| Datum | Klasse | Grund | Firma |
|---|---|---|---|
| 13. Apr. 2022 | II | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office |
| 26. Jan. 2022 | II | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | CARDINAL HEALTHCARE |
| 17. Nov. 2021 | I | Temperature Abuse; temperature excursion during shipping | Sandoz Inc |
| 11. März 2021 | II | Defective Delivery System: customer complaints concerning the injector pen breaking apart and disintegrating into pieces. | Ferring Pharmaceuticals Inc |
| 11. März 2021 | II | Defective Delivery System: customer complaints concerning the injector pen breaking apart and disintegrating into pieces. | Ferring Pharmaceuticals Inc |
| 2. Feb. 2021 | I | Labeling; Label Mixup; syringe barrels may containing markings for 150 mg/mL (corresponding to 120 mg/0.8mL strength) instead of 100 mg/mL markings (corresponding to 100 mg/mL strength) | Apotex Corp. |
| 2. Feb. 2021 | I | Labeling; Label Mixup; syringe barrels may contain markings for 100 mg/mL (corresponding to 100 mg/mL strength) instead of 150 mg/mL (corresponding to 120 mg/0.8mL strength) | Apotex Corp. |
| 24. Juli 2019 | II | Lack of Assurance of Sterility: product sterility cannot be guaranteed. | Colonia Care Pharmacy |
| 14. Aug. 2018 | III | Defective Delivery System: Water ingress through the lower water cup sensor of the device. | United Therapeutics Corp. |
| 12. Feb. 2016 | II | Lack of Assurance of Sterility | Walter's Pharmacy |
| 21. 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. 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 |
Klasse I = begründete Wahrscheinlichkeit schwerwiegender Schäden · Klasse II = vorübergehend oder reversibel · Klasse III = Schaden unwahrscheinlich.
Registrierungsstatus
Einige Produkte von Blue Echo Care LLC 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.