Profil du fabricant
Baxter Healthcare Company
Société pharmaceutique3 produits suivis
3
produits suivis
197 972
total des notifications
34
rappels enregistrés
96,3%
graves au total
Produits
affichage de 3 sur 3
| Produit | Approuvé | Notifications ↓ | Signal principal | Rappels |
|---|---|---|---|---|
| — | 172 252 | Neutropénie fébrile | 0 | |
| 1987 | 20 887 | Lymphome diffus à grandes cellules B récurrent | 3 | |
| 1964 | 4 833 | appendicolithe | 31 |
Historique des rappels · 24 enregistrés
| Date | Classe | Motif | Fabricant |
|---|---|---|---|
| 8 mars 2022 | II | Super Potent and Failed Reconstitution Time | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| 8 mars 2022 | II | Product found to be Sub Potent or Exceeded reconstitution time | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| 8 mars 2022 | III | Sub Potent | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| 8 mars 2022 | II | Sub Potent | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| 8 mars 2022 | III | Super Potent | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| 20 nov. 2020 | II | CGMP deviations: Lack of potency testing. | Complete Pharmacy and Medical Solutions, LLC. |
| 20 nov. 2020 | II | CGMP deviations: Lack of potency testing. | Complete Pharmacy and Medical Solutions, LLC. |
| 20 nov. 2020 | II | CGMP deviations: Lack of potency testing. | Complete Pharmacy and Medical Solutions, LLC. |
| 20 nov. 2020 | II | CGMP deviations: Lack of potency testing. | Complete Pharmacy and Medical Solutions, LLC. |
| 12 juin 2019 | II | Lack of Assurance of Sterility | Infusion Options, Inc. |
| 10 sept. 2018 | II | Lack of Assurance of Sterility | Pharm D Solutions, LLC |
| 10 sept. 2018 | II | Lack of Assurance of Sterility | Pharm D Solutions, LLC |
| 10 sept. 2018 | II | Lack of Assurance of Sterility | Pharm D Solutions, LLC |
| 10 sept. 2018 | II | Lack of Assurance of Sterility | Pharm D Solutions, LLC |
| 10 sept. 2018 | II | Lack of Assurance of Sterility | Pharm D Solutions, LLC |
| 15 août 2017 | II | Lack of Assurance of Sterility. | Bella Pharmaceuticals, Inc. |
| 8 mars 2016 | II | Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin. | Hospira Inc. |
| 2 juin 2015 | II | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America |
| 27 août 2014 | II | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance. | Martin Avenue Pharmacy, Inc. |
| 27 août 2014 | II | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance. | Martin Avenue Pharmacy, Inc. |
| 12 mai 2014 | II | Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products. | John W Hollis Inc |
| 13 sept. 2013 | II | Temperature abuse: Certain vials of Ifosfamide IV products were not refrigerated at certain Amerisource Bergen Drug Corp distribution centers. | AmeriSource Bergen |
| 13 sept. 2013 | II | Temperature abuse: Certain vials of Ifosfamide IV products were not refrigerated at certain Amerisource Bergen Drug Corp distribution centers. | AmeriSource Bergen |
| 28 mai 2013 | II | The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. | Main Street Family Pharmacy, LLC |
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 Baxter Healthcare Company 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.