Profil du fabricant
Asclemed USA, Inc.
Société pharmaceutique6 produits suivis
6
produits suivis
333 041
total des notifications
36
rappels enregistrés
64,0%
graves au total
Produits
affichage de 6 sur 6
| Produit | Approuvé | Notifications ↓ | Signal principal | Rappels |
|---|---|---|---|---|
| — | 246 995 | Réaction liée à la perfusion | 0 | |
| 1995 | 68 558 | Syndrome de libération de cytokines | 0 | |
| 1996 | 6 095 | Strongyloïdose | 1 | |
| 1992 | 5 509 | Gêne nasale | 33 | |
| 1962 | 3 299 | Suicide accompli | 2 | |
| — | 2 585 | vertige | 0 |
Historique des rappels · 32 enregistrés
| Date | Classe | Motif | Fabricant |
|---|---|---|---|
| 1 oct. 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 avr. 2023 | II | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. |
| 13 oct. 2022 | II | CGMP Deviations: | Akorn, Inc. |
| 15 mars 2021 | II | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. |
| 23 déc. 2020 | I | Presence of Particulate Matter - found in reserve sample vials at the firm. | Fresenius Kabi USA, LLC |
| 17 déc. 2020 | II | Presence of Particulate Matter - found in reserve sample vials at the firm. | Fresenius Kabi USA, LLC |
| 20 avr. 2020 | II | Presence of Particulate Matter - found in reserve sample vials at the firm. | Fresenius Kabi USA, LLC |
| 20 avr. 2020 | I | Presence of Particulate Matter - found in reserve sample vials at the firm. | Fresenius Kabi USA, LLC |
| 17 déc. 2019 | I | Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS) | Hikma Pharmaceuticals USA Inc. |
| 17 déc. 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 avr. 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 août 2017 | II | Crystallization: Particulate matter (Ketorolac Calcium Salt) was observed from several lots of retained samples. | Amphastar Pharmaceuticals, Inc. |
| 30 juin 2015 | II | Crystallization; identified as calcium salt of Ketorolac | Hospira Inc. |
| 30 juin 2015 | II | Crystallization; identified as calcium salt of Ketorolac | Hospira Inc. |
| 13 avr. 2015 | II | Crystallization | Hospira Inc. |
| 13 avr. 2015 | II | Crystallization | Hospira Inc. |
| 23 janv. 2015 | II | Crystallization | Hospira Inc. |
| 23 janv. 2015 | II | Crystallization | Hospira Inc. |
| 21 janv. 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 oct. 2014 | II | Temperature Abuse: Products experienced uncontrolled temperature excursions during transit. | Hospira Inc. |
| 3 oct. 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 août 2013 | II | Lack of Assurance of Sterility: Either a loose crimp or no crimp was applied to the fliptop vials. | Hospira, Inc. |
| 26 juil. 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 juil. 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 |
Classe I = probabilité raisonnable de préjudice grave · Classe II = temporaire ou réversible · Classe III = peu susceptible de causer un préjudice.
Statut d'enregistrement
Certains produits de Asclemed USA, Inc. ne sont pas enregistrés auprès de la FDA pour un usage humain. Pour les substances non enregistrées (peptides, SARMs sans enregistrement humain), aucun fournisseur légitime à usage humain n'existe. L'absence de filière d'approvisionnement est l'information de sécurité.