Chartwell RX, LLC

Farmaceutisch bedrijf8 producten gevolgd

producten gevolgd

358.763

totaal meldingen

recalls geregistreerd

72,8%

ernstig algeheel

Producten

8 van 8 getoond

Product	Goedgekeurd	Meldingen ↓	Top signaal	Recalls
escitalopram —	2002	136.935	poging tot zelfdoding	2
leflunomide —	1998	102.951	anti-cyclisch citrulline peptide antistof positief	4
diazepam oral solution (concentrate) —	—	87.168	medicijnmisbruik	1
posaconazole delayed-release —	—	10.528	Mucormycose	1
cimetidine —	1977	9.348	ernstige nierziekte	3
sterile water —	1970	4.851	Erfelijke angio-oedeem	72
cyproheptadine hydrochloride —	1979	4.297	infectie van de longen bij cystische fibrose	2
bupropion hydrochloride (xl) —	—	2.685	probleem met productvervanging	0

Recall-geschiedenis · 39 geregistreerd

Datum	Klasse	Reden	Bedrijf
2 apr 2026	II	Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.	B BRAUN MEDICAL INC
22 dec 2025	II	Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution	Baxter Healthcare Corporation
26 aug 2025	II	Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.	B BRAUN MEDICAL INC
26 apr 2023	II	CGMP Deviations: Firm went out of business and could no longer continue stability studies.	Akorn, Inc.
13 apr 2022	II	cGMP deviations: Temperature abuse	Mckesson Medical-Surgical Inc. Corporate Office
4 apr 2022	II	CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated	Olympia Compounding Pharmacy dba Olympia Pharmacy
29 jul 2021	II	Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.	PAI Holdings, LLC. dba Pharmaceutical Associates Inc
3 mei 2021	II	Presence of Particulate Matter: particulate matter identified as an insect in one vial.	Pfizer Inc.
19 jun 2019	II	Lack of Assurance of Sterility	RXQ Compounding LLC
21 mei 2019	II	cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).	Torrent Pharma Inc
13 mrt 2019	II	Lack of Assurance of Sterility	Advanced Pharma Inc.
29 nov 2018	I	Labeling: Label Error on Declared Strength: Label incorrectly lists concentration as "10 mcg per mL" rather than the correct concentration of "100 mcg per mL".	Advanced Pharma Inc.
10 sep 2018	II	Lack of Assurance of Sterility	Pharm D Solutions, LLC
27 dec 2017	II	Lack of sterility assurance.	Pharmedium Services, LLC
1 sep 2017	II	Non-Sterility: cracked or chipped glass at the neck of Sterile Water for Injection vials.	Pfizer Inc.
20 sep 2016	II	Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters	Leiter's Compounding
16 aug 2016	I	Non Sterility; contaminated with Klebsiella pneumoniae	Sperian Eye & Face Protection, Inc
7 jun 2016	III	Subpotency: product assayed and found OOS for cyproheptadine	Lyne Laboratories, Inc.
20 apr 2016	II	Lack of Assurance of Sterility	Pharmakon Pharmaceuticals, Inc.
18 apr 2016	II	Lack of Sterility Assurance	Baptist Health Medical Towers Pharmacy and Infusion Services
24 mrt 2016	III	Labeling: Incorrect or Missing Lot and/or Expiration Date	Lupin Limited
16 feb 2016	II	Presence of Particulate Matter: Glass particles found in the product after reconstitution.	Genzyme Corporation
28 mei 2015	II	Lack of Assurance of Sterility: Sterility of product is not assured.	Lincare, Inc.
18 mei 2015	II	Lack of Assurance of Sterility	Advanced Physician Solutions, Inc.
18 mei 2015	II	Lack of Assurance of Sterility	Advanced Physician Solutions, Inc.
18 mei 2015	II	Lack of Assurance of Sterility	Advanced Physician Solutions, Inc.
18 mei 2015	II	Lack of Assurance of Sterility	Advanced Physician Solutions, Inc.
26 dec 2014	II	Lack of sterility assurance.	Walgreens Infusion Services
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
14 okt 2014	II	Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.	Hospira Inc.
15 mei 2014	II	Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.	Franck's Lab Inc dba Trinity Care Solutions
15 mei 2014	II	Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.	Franck's Lab Inc dba Trinity Care Solutions
29 apr 2014	II	Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling indicates it is to be used for parenteral injection.	Flawless Beauty LLC
19 okt 2013	I	Non-Sterility: 50% dextrose is being recalled after particulate matter, later identified as mold, was found floating in the product.	Specialty Medicine Compounding Pharmacy, P.C.
2 jul 2013	II	Labeling: Label Mixup; LEFLUNOMIDE Tablet, 10 mg may be potentially mislabeled as DOXYCYCLINE HYCLATE, Capsule, 100 mg, NDC 00143314250, Pedigree: W002645, EXP: 6/5/2014; SEVELAMER CARBONATE, Tablet, 800 mg, NDC 58468013001, Pedigree: W002623, EXP: 6/4/2014.	Aidapak Services, LLC
2 jul 2013	II	Labeling: Label Mixup: ESCITALOPRAM, Tablet, 5 mgmay have potentially been mislabeled as the following drug: SODIUM CHLORIDE, Tablet, 1 gm, NDC 00223176001, Pedigree: W003707, EXP: 6/25/2014.	Aidapak Services, LLC
14 jun 2007	II	Subpotent (Single Ingredient Drug): Distribution of product that did not meet specifications.	Apotex Corp.
14 jun 2007	II	Subpotent (Single Ingredient Drug): Distribution of product that did not meet specifications.	Apotex Corp.

Class I = redelijke kans op ernstige schade · Class II = tijdelijk of omkeerbaar · Class III = onwaarschijnlijk schadelijk.

Registratiestatus

Sommige producten van Chartwell RX, LLC 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.