Profil du fabricant
Boiron
Société pharmaceutique6 produits suivis
6
produits suivis
85 055
total des notifications
12
rappels enregistrés
81,3%
graves au total
Produits
affichage de 6 sur 6
| Produit | Approuvé | Notifications ↓ | Signal principal | Rappels |
|---|---|---|---|---|
| 1946 | 48 897 | Maladie rénale chronique | 10 | |
| — | 22 469 | Immunodéficience | 0 | |
| 2005 | 8 945 | Abus de drogues | 2 | |
| — | 4 170 | problème de substitution de produit | 0 | |
| — | 572 | Flatulence vaginale | 0 | |
| — | 2 | — | 0 |
Historique des rappels · 12 enregistrés
| Date | Classe | Motif | Fabricant |
|---|---|---|---|
| 17 févr. 2025 | II | Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes. | Safecor Health, LLC |
| 26 avr. 2023 | II | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. |
| 15 mars 2021 | II | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. |
| 31 mai 2019 | II | cGMP Deviations: Products may have microbial contamination. | Geritrex, LLC |
| 31 mai 2019 | II | cGMP Deviations: Products may have microbial contamination. | Geritrex, LLC |
| 7 mai 2018 | II | CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample. | RIJ Pharmaceutical LLC |
| 10 avr. 2018 | III | Presence of Foreign Tablets/Capsules | Aidarex Pharmaceuticals LLC |
| 25 mars 2016 | II | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy |
| 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 |
| 2 juil. 2013 | II | Labeling: Label Mixup; FERROUS SULFATE, Tablet, 325 mg (65 mg Elemental Iron) may be potentially mislabeled as RAMIPRIL, Capsule, 2.5 mg, NDC 68180058901, Pedigree: AD54549_16, EXP: 5/20/2014. | Aidapak Services, LLC |
| 2 juil. 2013 | II | Labeling: Label Mixup; FERROUS SULFATE, Tablet, 325 mg (65 mg Elem Fe) may be potentially mislabeled as COENZYME Q-10, Capsule, 100 mg, NDC 37205055065, Pedigree: W002711, EXP: 6/6/2014; VENLAFAXINE HCL, Tablet, 25 mg, NDC 00093019901, Pedigree: W002825, EXP: 12/31/2013; DOCUSATE SODIUM, Capsule, 250 mg, NDC 00536375710, Pedigree: AD60236_1, EXP: 5/22/2014. | Aidapak Services, LLC |
| 28 déc. 2012 | I | Labeling; Label Mixup; bottles of Ferrous Sulfate actually contains Meclizine HCl (indicated for motion sickness) | Advance Pharmaceutical Inc |
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 Boiron 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.