Herstellerprofil
American Regent, Inc.
Pharmaunternehmen4 erfasste Produkte
4
erfasste Produkte
19.384
Meldungen insgesamt
4
dokumentierte Rückrufe
63,4%
schwerwiegend insgesamt
Produkte
4 von 4 angezeigt
| Produkt | Zugelassen | Meldungen ↓ | Top-Signal | Rückrufe |
|---|---|---|---|---|
| 1978 | 8.660 | Produktablagerung | 0 | |
| 2013 | 4.574 | Hypophosphatämie | 1 | |
| — | 4.574 | Hypophosphatämie | 0 | |
| 1986 | 1.576 | Entzündung des Nagelbetts | 3 |
Rückrufhistorie · 11 dokumentiert
| Datum | Klasse | Grund | Firma |
|---|---|---|---|
| 16. Apr. 2026 | III | Labeling: Missing Label | American Regent, Inc. |
| 18. Apr. 2025 | II | Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance. | American Regent, Inc. |
| 18. Apr. 2025 | II | Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance. | American Regent, Inc. |
| 11. Nov. 2024 | II | Presence of Particulate Matter: Potential for glass delamination from the vials. | American Regent, Inc. |
| 11. Nov. 2024 | II | Presence of Particulate Matter: Potential for glass delamination from the vials. | American Regent, Inc. |
| 11. Nov. 2024 | II | Presence of Particulate Matter: Potential for glass delamination from the vials. | American Regent, Inc. |
| 14. Mai 2024 | II | Lack of Assurance of Sterility. | American Regent, Inc. |
| 18. Juni 2019 | II | Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance. | Premier Pharmacy Labs Inc |
| 12. Juni 2019 | II | Lack of Assurance of Sterility | Infusion Options, Inc. |
| 24. Feb. 2015 | II | Presence of particulate. | SCA Pharmaceuticals |
| 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 |
Klasse I = begründete Wahrscheinlichkeit schwerwiegender Schäden · Klasse II = vorübergehend oder reversibel · Klasse III = Schaden unwahrscheinlich.
Registrierungsstatus
Einige Produkte von American Regent, 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.