Herstellerprofil
Actavis Pharma, Inc.
Pharmaunternehmen2 erfasste Produkte
2
erfasste Produkte
39.164
Meldungen insgesamt
12
dokumentierte Rückrufe
87,6%
schwerwiegend insgesamt
Produkte
2 von 2 angezeigt
| Produkt | Zugelassen | Meldungen ↓ | Top-Signal | Rückrufe |
|---|---|---|---|---|
| 1988 | 37.667 | Leber-Enzephalopathie | 9 | |
| 1988 | 1.497 | Rebound-Säurehypersekretion | 3 |
Rückrufhistorie · 11 dokumentiert
| Datum | Klasse | Grund | Firma |
|---|---|---|---|
| 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. Mai 2019 | II | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). | Torrent Pharma Inc |
| 21. Mai 2019 | II | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). | Torrent Pharma Inc |
| 26. Juni 2017 | II | Microbial contamination of non-sterile product: product failed Total Yeast/Mold Count specification. | VistaPharm, Inc. |
| 26. Juni 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. |
Klasse I = begründete Wahrscheinlichkeit schwerwiegender Schäden · Klasse II = vorübergehend oder reversibel · Klasse III = Schaden unwahrscheinlich.
Registrierungsstatus
Einige Produkte von Actavis Pharma, Inc. 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.