Asclemed USA, Inc.

Farmaceutisch bedrijf6 producten gevolgd

producten gevolgd

333.041

totaal meldingen

recalls geregistreerd

64,0%

ernstig algeheel

Producten

6 van 6 getoond

Product	Goedgekeurd	Meldingen ↓	Top signaal	Recalls
acetaminophen tablet extended release —	—	246.995	infuusgerelateerde reactie	0
valacyclovir hydrochloride —	1995	68.558	Cytokinestorm	0
ivermectin —	1996	6.095	strongyloidiasis	1
ketorolac tromethamine —	1992	5.509	neusklachten	33
metaxalone —	1962	3.299	voltooide zelfmoord	2
meclizine hydrocloride —	—	2.585	duizeligheid	0

Recall-geschiedenis · 32 geregistreerd

Datum	Klasse	Reden	Bedrijf
1 okt 2025	II	Presence of Particulate Matter: Particulate matter identified as glass	Aspiro Pharma Limited
5 sep 2025	II	Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns	Apotex Corp.
28 mei 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 mrt 2021	II	CGMP Deviations: Intermittent exposure to temperature excursion during storage.	Cardinal Health Inc.
23 dec 2020	I	Presence of Particulate Matter - found in reserve sample vials at the firm.	Fresenius Kabi USA, LLC
17 dec 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 dec 2019	I	Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS)	Hikma Pharmaceuticals USA Inc.
17 dec 2019	II	Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS)	Hikma Pharmaceuticals USA Inc.
12 sep 2019	II	Lack of Assurance of Sterility	KRS Global Biotechnology, Inc
12 sep 2019	II	Lack of Assurance of Sterility	KRS Global Biotechnology, Inc
12 sep 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 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 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 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 mei 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

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Registratiestatus

Sommige producten van Asclemed USA, Inc. zijn niet FDA-geregistreerd voor humaan gebruik. Voor ongeregistreerde stoffen (peptiden, SARMs zonder humane registratie) bestaat geen legitieme leverancier voor humaan gebruik. Het ontbreken van een inkooproute is de veiligheidsinformatie.