Fabrikant-profiel
Actavis Pharma, Inc.
Farmaceutisch bedrijf2 producten gevolgd
2
producten gevolgd
39.164
totaal meldingen
12
recalls geregistreerd
87,6%
ernstig algeheel
Producten
2 van 2 getoond
| Product | Goedgekeurd | Meldingen ↓ | Top signaal | Recalls |
|---|---|---|---|---|
| 1988 | 37.667 | leverencefalopathie | 9 | |
| 1988 | 1.497 | Rebound maagzuurproductie | 3 |
Recall-geschiedenis · 11 geregistreerd
| Datum | Klasse | Reden | Bedrijf |
|---|---|---|---|
| 26 apr 2023 | II | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. |
| 26 apr 2023 | II | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. |
| 7 jan 2020 | II | CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the API Nizatidine. | Mylan Pharmaceuticals Inc. |
| 7 jan 2020 | II | CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the API Nizatidine. | Mylan Pharmaceuticals Inc. |
| 21 mei 2019 | II | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). | Torrent Pharma Inc |
| 21 mei 2019 | II | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). | Torrent Pharma Inc |
| 26 jun 2017 | II | Microbial contamination of non-sterile product: product failed Total Yeast/Mold Count specification. | VistaPharm, Inc. |
| 26 jun 2017 | II | Microbial contamination of non-sterile product: product failed Total Yeast/Mold Count specification. | VistaPharm, Inc. |
| 18 jan 2017 | II | CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia. | VistaPharm, Inc. |
| 18 jan 2017 | II | CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia. | VistaPharm, Inc. |
| 9 nov 2016 | II | Microbial Contamination of Non-Sterile Products: bulk solution tested positive for the presence of the bacteria, Burkholderia cepacia. | VistaPharm, Inc. |
Class I = redelijke kans op ernstige schade · Class II = tijdelijk of omkeerbaar · Class III = onwaarschijnlijk schadelijk.
Registratiestatus
Sommige producten van Actavis Pharma, Inc. 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.