Profil du fabricant
Blue Echo Care LLC
Société pharmaceutique2 produits suivis
2
produits suivis
1 439 995
total des notifications
14
rappels enregistrés
18,2%
graves au total
Produits
Historique des rappels · 11 enregistrés
| Date | Classe | Motif | Fabricant |
|---|---|---|---|
| 13 avr. 2022 | II | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office |
| 26 janv. 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 mars 2021 | II | Defective Delivery System: customer complaints concerning the injector pen breaking apart and disintegrating into pieces. | Ferring Pharmaceuticals Inc |
| 11 mars 2021 | II | Defective Delivery System: customer complaints concerning the injector pen breaking apart and disintegrating into pieces. | Ferring Pharmaceuticals Inc |
| 2 févr. 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 févr. 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 juil. 2019 | II | Lack of Assurance of Sterility: product sterility cannot be guaranteed. | Colonia Care Pharmacy |
| 14 août 2018 | III | Defective Delivery System: Water ingress through the lower water cup sensor of the device. | United Therapeutics Corp. |
| 12 févr. 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 |
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 Blue Echo Care LLC 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.