Herstellerprofil
Boiron
Pharmaunternehmen6 erfasste Produkte
6
erfasste Produkte
85.055
Meldungen insgesamt
12
dokumentierte Rückrufe
81,3%
schwerwiegend insgesamt
Produkte
6 von 6 angezeigt
| Produkt | Zugelassen | Meldungen ↓ | Top-Signal | Rückrufe |
|---|---|---|---|---|
| 1946 | 48.897 | Chronische Nierenerkrankung | 10 | |
| — | 22.469 | Immunschwäche | 0 | |
| 2005 | 8.945 | Drogenmissbrauch | 2 | |
| — | 4.170 | Problem bei Produktaustausch | 0 | |
| — | 572 | Vaginale Blähungen | 0 | |
| — | 2 | — | 0 |
Rückrufhistorie · 12 dokumentiert
| Datum | Klasse | Grund | Firma |
|---|---|---|---|
| 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. März 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. Apr. 2018 | III | Presence of Foreign Tablets/Capsules | Aidarex Pharmaceuticals LLC |
| 25. März 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. Juli 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. Juli 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. Dez. 2012 | I | Labeling; Label Mixup; bottles of Ferrous Sulfate actually contains Meclizine HCl (indicated for motion sickness) | Advance Pharmaceutical Inc |
Klasse I = begründete Wahrscheinlichkeit schwerwiegender Schäden · Klasse II = vorübergehend oder reversibel · Klasse III = Schaden unwahrscheinlich.
Registrierungsstatus
Einige Produkte von Boiron sind nicht für die Anwendung am Menschen FDA-registriert. Für nicht registrierte Substanzen (Peptide, SARMs ohne Humanzulassung) existiert kein legitimer Anbieter für die Anwendung am Menschen. Das Fehlen eines Bezugswegs ist die Sicherheitsinformation.