Herstellerprofil
Asclemed USA, Inc.
Pharmaunternehmen6 erfasste Produkte
6
erfasste Produkte
333.041
Meldungen insgesamt
36
dokumentierte Rückrufe
64,0%
schwerwiegend insgesamt
Produkte
6 von 6 angezeigt
| Produkt | Zugelassen | Meldungen ↓ | Top-Signal | Rückrufe |
|---|---|---|---|---|
| — | 246.995 | Infusionsbedingte Reaktion | 0 | |
| 1995 | 68.558 | Zytokinfreisetzungssyndrom | 0 | |
| 1996 | 6.095 | Strongyloidiasis | 1 | |
| 1992 | 5.509 | Nasenbeschwerden | 33 | |
| 1962 | 3.299 | Vollendeter Suizid | 2 | |
| — | 2.585 | Schwindel | 0 |
Rückrufhistorie · 32 dokumentiert
| Datum | Klasse | Grund | Firma |
|---|---|---|---|
| 1. Okt. 2025 | II | Presence of Particulate Matter: Particulate matter identified as glass | Aspiro Pharma Limited |
| 5. Sept. 2025 | II | Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns | Apotex Corp. |
| 28. Mai 2025 | II | Lack of Assurance of Sterility | Apotex Corp. |
| 26. Apr. 2023 | II | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. |
| 13. Okt. 2022 | II | CGMP Deviations: | Akorn, Inc. |
| 15. März 2021 | II | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. |
| 23. Dez. 2020 | I | Presence of Particulate Matter - found in reserve sample vials at the firm. | Fresenius Kabi USA, LLC |
| 17. Dez. 2020 | II | Presence of Particulate Matter - found in reserve sample vials at the firm. | Fresenius Kabi USA, LLC |
| 20. Apr. 2020 | II | Presence of Particulate Matter - found in reserve sample vials at the firm. | Fresenius Kabi USA, LLC |
| 20. Apr. 2020 | I | Presence of Particulate Matter - found in reserve sample vials at the firm. | Fresenius Kabi USA, LLC |
| 17. Dez. 2019 | I | Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS) | Hikma Pharmaceuticals USA Inc. |
| 17. Dez. 2019 | II | Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS) | Hikma Pharmaceuticals USA Inc. |
| 12. Sept. 2019 | II | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc |
| 12. Sept. 2019 | II | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc |
| 12. Sept. 2019 | II | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc |
| 30. Apr. 2019 | II | Lack of Sterility Assurance: Microbial growth detected during a routine simulation of the manufacturing process, which represents the potential introduction of microorganisms into the products. | Sagent Pharmaceuticals Inc |
| 15. Aug. 2017 | II | Crystallization: Particulate matter (Ketorolac Calcium Salt) was observed from several lots of retained samples. | Amphastar Pharmaceuticals, Inc. |
| 30. Juni 2015 | II | Crystallization; identified as calcium salt of Ketorolac | Hospira Inc. |
| 30. Juni 2015 | II | Crystallization; identified as calcium salt of Ketorolac | Hospira Inc. |
| 13. Apr. 2015 | II | Crystallization | Hospira Inc. |
| 13. Apr. 2015 | II | Crystallization | Hospira Inc. |
| 23. Jan. 2015 | II | Crystallization | Hospira Inc. |
| 23. Jan. 2015 | II | Crystallization | Hospira Inc. |
| 21. Jan. 2015 | II | Presence of Particulate Matter: lot is not meeting the specification limit for number of particles present in the solution. | Sun Pharma Global Fze |
| 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 |
| 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 |
| 6. Okt. 2014 | II | Temperature Abuse: Products experienced uncontrolled temperature excursions during transit. | Hospira Inc. |
| 3. Okt. 2014 | II | Incorrect or Missing Lot and/or Exp Date: Ketorolac Tromethamine Injection, is being recalled as a result of labeling the product with the incorrect expiration date. | Sagent Pharmaceuticals Inc |
| 12. Aug. 2013 | II | Lack of Assurance of Sterility: Either a loose crimp or no crimp was applied to the fliptop vials. | Hospira, Inc. |
| 26. Juli 2013 | II | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance | Beacon Hill Medical Pharmacy, P.C. |
| 2. Juli 2013 | II | Labeling: Label Mixup; METAXALONE Tablet, 800 mg may be potentially mislabeled as ESTERIFIED ESTROGENS, Tablet, 0.625 mg, NDC 61570007301, Pedigree: W003736, EXP: 6/26/2014. | Aidapak Services, LLC |
| 21. Mai 2012 | II | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. | Franck's Lab Inc., d.b.a. Franck's Compounding Lab |
Klasse I = begründete Wahrscheinlichkeit schwerwiegender Schäden · Klasse II = vorübergehend oder reversibel · Klasse III = Schaden unwahrscheinlich.
Registrierungsstatus
Einige Produkte von Asclemed USA, 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.