Fabrikant-profiel
Bausch & Lomb Incorporated
Farmaceutisch bedrijf4 producten gevolgd
4
producten gevolgd
73.260
totaal meldingen
23
recalls geregistreerd
47,8%
ernstig algeheel
Producten
4 van 4 getoond
| Product | Goedgekeurd | Meldingen ↓ | Top signaal | Recalls |
|---|---|---|---|---|
| 2001 | 27.882 | verhoogde intraoculaire druk | 9 | |
| 2001 | 27.882 | verhoogde intraoculaire druk | 10 | |
| 2016 | 16.017 | reactie op instillatieplaats | 4 | |
| — | 1.479 | polipoïde vaatziekte van het vaatvlies | 0 |
Recall-geschiedenis · 14 geregistreerd
| Datum | Klasse | Reden | Bedrijf |
|---|---|---|---|
| 5 mrt 2026 | II | Lack of Assurance of Sterility | Apotex Corp. |
| 5 sep 2025 | II | Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns | Apotex Corp. |
| 28 mei 2025 | II | Lack of Assurance of Sterility | Apotex Corp. |
| 1 mrt 2023 | II | Lack of sterility assurance: Cracks have developed in some of the units caps of Brimonidine tartrate ophthalmic solution bottles. There is a possibility the broken cap may impact sterility. | Apotex Corp. |
| 10 mei 2022 | III | Failed Impurities/Degradation Specifications. | Novartis Pharmaceuticals Corporation |
| 10 mei 2022 | III | Failed Impurities/Degradation Specifications. | Novartis Pharmaceuticals Corporation |
| 10 mei 2022 | III | Failed Impurities/Degradation Specifications. | Novartis Pharmaceuticals Corporation |
| 10 mei 2022 | III | Failed Impurities/Degradation Specifications. | Novartis Pharmaceuticals Corporation |
| 4 jun 2020 | III | Failed Impurities/Degradation Specification: There is a slow leaching process from the product label on the bottle which may impact the product over the shelf life. | SOMERSET THERAPEUTICS LLC |
| 4 jun 2020 | III | Failed Impurities/Degradation Specification: There is a slow leaching process from the product label on the bottle which may impact the product over the shelf life. | SOMERSET THERAPEUTICS LLC |
| 4 jun 2020 | III | Failed Impurities/Degradation Specification: There is a slow leaching process from the product label on the bottle which may impact the product over the shelf life. | SOMERSET THERAPEUTICS LLC |
| 19 mrt 2019 | II | cGMP Deviations | Allergan Sales, LLC |
| 19 okt 2017 | III | Failed Impurities/Degradation Specifications. | Allergan Sales, LLC |
| 23 jun 2017 | II | Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier | ImprimisRx CA, Inc., dba ImprimisRx |
Class I = redelijke kans op ernstige schade · Class II = tijdelijk of omkeerbaar · Class III = onwaarschijnlijk schadelijk.
Registratiestatus
Sommige producten van Bausch & Lomb Incorporated 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.