Fabrikant-profiel
Blue Echo Care LLC
Farmaceutisch bedrijf2 producten gevolgd
2
producten gevolgd
1.439.995
totaal meldingen
14
recalls geregistreerd
18,2%
ernstig algeheel
Producten
Recall-geschiedenis · 11 geregistreerd
| Datum | Klasse | Reden | Bedrijf |
|---|---|---|---|
| 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 mrt 2021 | II | Defective Delivery System: customer complaints concerning the injector pen breaking apart and disintegrating into pieces. | Ferring Pharmaceuticals Inc |
| 11 mrt 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 jul 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 mei 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 |
Class I = redelijke kans op ernstige schade · Class II = tijdelijk of omkeerbaar · Class III = onwaarschijnlijk schadelijk.
Registratiestatus
Sommige producten van Blue Echo Care LLC zijn niet FDA-geregistreerd voor humaan gebruik. Voor ongeregistreerde stoffen (peptiden, SARMs zonder humane registratie) bestaat geen legitieme leverancier voor humaan gebruik. Het ontbreken van een inkooproute is de veiligheidsinformatie.