Chartwell RX, LLC

Pharmaunternehmen8 erfasste Produkte

erfasste Produkte

358.763

Meldungen insgesamt

dokumentierte Rückrufe

72,8%

schwerwiegend insgesamt

Produkte

8 von 8 angezeigt

Produkt	Zugelassen	Meldungen ↓	Top-Signal	Rückrufe
escitalopram —	2002	136.935	Suizidversuch	2
leflunomide —	1998	102.951	Anti-zyklisch-citrullinierte Peptid-Antikörper positiv	4
diazepam oral solution (concentrate) —	—	87.168	Drogenmissbrauch	1
posaconazole delayed-release —	—	10.528	Mukormykose	1
cimetidine —	1977	9.348	Nierenversagen im Endstadium	3
sterile water —	1970	4.851	Erbödem	72
cyproheptadine hydrochloride —	1979	4.297	Infektiöse Lungenverschlimmerung bei Mukoviszidose	2
bupropion hydrochloride (xl) —	—	2.685	Problem bei Produktaustausch	0

Rückrufhistorie · 39 dokumentiert

Datum	Klasse	Grund	Firma
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. Dez. 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. Juli 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. Mai 2021	II	Presence of Particulate Matter: particulate matter identified as an insect in one vial.	Pfizer Inc.
19. Juni 2019	II	Lack of Assurance of Sterility	RXQ Compounding LLC
21. Mai 2019	II	cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).	Torrent Pharma Inc
13. März 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. Sept. 2018	II	Lack of Assurance of Sterility	Pharm D Solutions, LLC
27. Dez. 2017	II	Lack of sterility assurance.	Pharmedium Services, LLC
1. Sept. 2017	II	Non-Sterility: cracked or chipped glass at the neck of Sterile Water for Injection vials.	Pfizer Inc.
20. Sept. 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. Juni 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. März 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. Mai 2015	II	Lack of Assurance of Sterility: Sterility of product is not assured.	Lincare, Inc.
18. Mai 2015	II	Lack of Assurance of Sterility	Advanced Physician Solutions, Inc.
18. Mai 2015	II	Lack of Assurance of Sterility	Advanced Physician Solutions, Inc.
18. Mai 2015	II	Lack of Assurance of Sterility	Advanced Physician Solutions, Inc.
18. Mai 2015	II	Lack of Assurance of Sterility	Advanced Physician Solutions, Inc.
26. Dez. 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. Mai 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. Mai 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. Juli 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. Juli 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. Juni 2007	II	Subpotent (Single Ingredient Drug): Distribution of product that did not meet specifications.	Apotex Corp.
14. Juni 2007	II	Subpotent (Single Ingredient Drug): Distribution of product that did not meet specifications.	Apotex Corp.

Klasse I = begründete Wahrscheinlichkeit schwerwiegender Schäden · Klasse II = vorübergehend oder reversibel · Klasse III = Schaden unwahrscheinlich.

Registrierungsstatus

Einige Produkte von Chartwell RX, LLC 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.