Asclemed USA, Inc.

Compañía farmacéutica6 productos registrados

productos registrados

333.041

notificaciones totales

retiradas registradas

64,0%

graves en total

Productos

mostrando 6 de 6

Producto	Aprobado	Notificaciones ↓	Señal principal	Retiradas
acetaminophen tablet extended release —	—	246.995	Reacción relacionada con la infusión	0
valacyclovir hydrochloride —	1995	68.558	Síndrome de liberación de citoquinas	0
ivermectin —	1996	6095	Estrongiloidiasis	1
ketorolac tromethamine —	1992	5509	Molestia nasal	33
metaxalone —	1962	3299	Suicidio consumado	2
meclizine hydrocloride —	—	2585	vértigo	0

Historial de retiradas · 32 registradas

Fecha	Clase	Motivo	Empresa
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 may 2025	II	Lack of Assurance of Sterility	Apotex Corp.
26 abr 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 mar 2021	II	CGMP Deviations: Intermittent exposure to temperature excursion during storage.	Cardinal Health Inc.
23 dic 2020	I	Presence of Particulate Matter - found in reserve sample vials at the firm.	Fresenius Kabi USA, LLC
17 dic 2020	II	Presence of Particulate Matter - found in reserve sample vials at the firm.	Fresenius Kabi USA, LLC
20 abr 2020	II	Presence of Particulate Matter - found in reserve sample vials at the firm.	Fresenius Kabi USA, LLC
20 abr 2020	I	Presence of Particulate Matter - found in reserve sample vials at the firm.	Fresenius Kabi USA, LLC
17 dic 2019	I	Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS)	Hikma Pharmaceuticals USA Inc.
17 dic 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 abr 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 ago 2017	II	Crystallization: Particulate matter (Ketorolac Calcium Salt) was observed from several lots of retained samples.	Amphastar Pharmaceuticals, Inc.
30 jun 2015	II	Crystallization; identified as calcium salt of Ketorolac	Hospira Inc.
30 jun 2015	II	Crystallization; identified as calcium salt of Ketorolac	Hospira Inc.
13 abr 2015	II	Crystallization	Hospira Inc.
13 abr 2015	II	Crystallization	Hospira Inc.
23 ene 2015	II	Crystallization	Hospira Inc.
23 ene 2015	II	Crystallization	Hospira Inc.
21 ene 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 ago 2013	II	Lack of Assurance of Sterility: Either a loose crimp or no crimp was applied to the fliptop vials.	Hospira, Inc.
26 jul 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 jul 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 may 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

Clase I = probabilidad razonable de daño grave · Clase II = temporal o reversible · Clase III = improbable que cause daño.

Estado de registro

Algunos productos de Asclemed USA, Inc. no están registrados por la FDA para uso humano. Para las sustancias no registradas (péptidos, SARM sin registro humano) no existe ningún proveedor legítimo para uso humano. La ausencia de una vía de aprovisionamiento es la información de seguridad.