Fabrikant-profiel
Boiron
Farmaceutisch bedrijf6 producten gevolgd
6
producten gevolgd
85.055
totaal meldingen
12
recalls geregistreerd
81,3%
ernstig algeheel
Producten
6 van 6 getoond
| Product | Goedgekeurd | Meldingen ↓ | Top signaal | Recalls |
|---|---|---|---|---|
| 1946 | 48.897 | chronische nierziekte | 10 | |
| — | 22.469 | immuundeficiëntie | 0 | |
| 2005 | 8.945 | medicijnmisbruik | 2 | |
| — | 4.170 | probleem met productvervanging | 0 | |
| — | 572 | winderigheid uit de vagina | 0 | |
| — | 2 | — | 0 |
Recall-geschiedenis · 12 geregistreerd
| Datum | Klasse | Reden | Bedrijf |
|---|---|---|---|
| 17 feb 2025 | II | Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes. | Safecor Health, LLC |
| 26 apr 2023 | II | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. |
| 15 mrt 2021 | II | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. |
| 31 mei 2019 | II | cGMP Deviations: Products may have microbial contamination. | Geritrex, LLC |
| 31 mei 2019 | II | cGMP Deviations: Products may have microbial contamination. | Geritrex, LLC |
| 7 mei 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 apr 2018 | III | Presence of Foreign Tablets/Capsules | Aidarex Pharmaceuticals LLC |
| 25 mrt 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 jul 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 jul 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 dec 2012 | I | Labeling; Label Mixup; bottles of Ferrous Sulfate actually contains Meclizine HCl (indicated for motion sickness) | Advance Pharmaceutical Inc |
Class I = redelijke kans op ernstige schade · Class II = tijdelijk of omkeerbaar · Class III = onwaarschijnlijk schadelijk.
Registratiestatus
Sommige producten van Boiron 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.