Recall-feed

Recente FDA-recalls

Over geneesmiddelen, hulpmiddelen, supplementen en cosmetica. Meest recent eerst. Bron: openFDA enforcement.

100 van 100 getoond

Datum ↓	Middel	Klasse	Reden	Bedrijf
9 mei 2022	nicotinamide	II	Lack of assurance of sterility.	Olympia Compounding Pharmacy dba Olympia Pharmacy
9 mei 2022	nicotinamide	II	Lack of assurance of sterility.	Olympia Compounding Pharmacy dba Olympia Pharmacy
9 mei 2022	glutathione	II	Lack of assurance of sterility.	Olympia Compounding Pharmacy dba Olympia Pharmacy
8 apr 2019	glutathione	II	Lack of assurance of sterility for injectables and solutions intended to be sterile.	Customceutical Compounding
7 mrt 2022	glutathione	II	Lack of Assurance of Sterility	TMC Acquisition LLC dba Tailor Made Compounding
7 mrt 2022	glutathione	II	Lack of Assurance of Sterility	TMC Acquisition LLC dba Tailor Made Compounding
6 okt 2014	glutathione	II	Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.	Oregon Compounding Centers, Inc. dba Creative Compounds
6 okt 2014	glutathione	II	Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.	Oregon Compounding Centers, Inc. dba Creative Compounds
5 sep 2014	glutathione	I	Non-Sterility: Failing sterility results were obtained from the recalling firm's contract testing facility indicating that the products may not be sterile.	Pharmacy Creations
30 nov 2020	copper peptide	II	Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.	Advanced Nutriceuticals, LLC
30 jul 2025	glutathione	II	Lack of Assurance of Sterility	GenoGenix LLC
30 jul 2025	copper peptide	II	Lack of Assurance of Sterility	GenoGenix LLC
30 jul 2025	glutathione	II	Lack of Assurance of Sterility	GenoGenix LLC
29 apr 2014	glutathione	II	Marketed Without An Approved NDA/ANDA: Parenteral product is labeled for use as an antidote.	Flawless Beauty LLC
29 apr 2014	glutathione	II	Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling indicates it is to be used parenterally for drug claims.	Flawless Beauty LLC
29 apr 2014	glutathione	II	Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling includes drug claims to act as an antidote.	Flawless Beauty LLC
27 apr 2016	somatropin	II	Defective Delivery System; may have a low frequency assembly fault which may result in pens block during the so-called "air shot" step	Novo Nordisk Inc
26 jun 2019	glutathione	II	Lack of Assurance of Sterility.	First Pharma Associates LLC dba Riverpoint Pharmacy
25 jun 2018	glutathione	II	Lack of Processing Controls: products produced in a manner that calls into question the sterility of the drug product intended to be sterile.	La Vita Compounding Pharmacy, LLC
25 jun 2014	glutathione	II	Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer	Medical Supply Liquidators Llc
24 mei 2022	nicotinamide	II	Lack of Assurance of Sterility	US Specialty Formulations LLC
24 jul 2015	glutathione	II	Lack of Assurance of Sterility; all sterile human compounded drugs within expiry	JD & SN Inc., dba Moses Lake Professional Pharmacy
24 jul 2015	glutathione	II	Lack of Assurance of Sterility; all sterile human compounded drugs within expiry	JD & SN Inc., dba Moses Lake Professional Pharmacy
23 mei 2019	nicotinamide	II	Lack of Sterility Assurance.	Pharm D Solutions, LLC
23 aug 2013	glutathione	II	Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable.	Wellness Pharmacy, Inc.
23 aug 2013	glutathione	II	Glutathione 100 mg/mL injectable human drug is recalled due to Out Of Specification results or potential bacterial contamination and it was reported as passing by a contract laboratory.	Creative Compounds
22 nov 2023	nicotinamide	II	Presence of Particulate Matter.	AnazaoHealth Corporation
22 mrt 2018	glutathione	II	Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.	Partell Specialty Pharmacy
22 dec 2022	nicotinamide	II	Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.	Pharmacy Innovations
22 dec 2022	nicotinamide	II	Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.	Pharmacy Innovations
22 dec 2022	glutathione	II	Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.	Pharmacy Innovations
21 sep 2016	glutathione	II	Lack of Assurance of Sterility	Wells Pharmacy Network LLC
21 aug 2018	glutathione	II	Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.	Auro Pharmacies, Inc.
2 jun 2015	glutathione	II	Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility	The Compounding Pharmacy of America
2 jun 2015	glutathione	II	Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility	The Compounding Pharmacy of America
2 jan 2019	glutathione	II	Lack of sterility assurance.	Hiers Enterprises, LLC dba Northwest Compounding Pharmacy
2 jan 2019	glutathione	II	Lack of sterility assurance.	Hiers Enterprises, LLC dba Northwest Compounding Pharmacy
19 okt 2017	bimatoprost	III	Failed Impurities/Degradation Specifications.	Allergan Sales, LLC
19 okt 2015	glutathione	II	Lack of Assurance of Sterility	Western Drug
19 okt 2015	glutathione	II	Lack of Assurance of Sterility	Western Drug
19 okt 2013	glutathione	II	Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.	Specialty Medicine Compounding Pharmacy
19 jun 2019	glutathione	II	Lack of Assurance of Sterility	RXQ Compounding LLC
19 jun 2019	nicotinamide	II	Lack of Assurance of Sterility	RXQ Compounding LLC
19 jun 2019	glutathione	II	Lack of Assurance of Sterility	RXQ Compounding LLC
19 jan 2018	glutathione	II	Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with Consent Decree of Permanent Injunction ordered by the United States District Court due to misbranding and unapproved new drugs pursuant to the FD&C Act.	Flawless Beauty LLC
19 jan 2018	glutathione	II	Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with Consent Decree of Permanent Injunction ordered by the United States District Court due to misbranding and unapproved new drugs pursuant to the FD&C Act.	Flawless Beauty LLC
19 jan 2018	glutathione	II	Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with Consent Decree of Permanent Injunction ordered by the United States District Court due to misbranding and unapproved new drugs pursuant to the FD&C Act.	Flawless Beauty LLC
19 jan 2018	glutathione	II	Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with Consent Decree of Permanent Injunction ordered by the United States District Court due to misbranding and unapproved new drugs pursuant to the FD&C Act.	Flawless Beauty LLC
19 jan 2018	glutathione	II	Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with Consent Decree of Permanent Injunction ordered by the United States District Court due to misbranding and unapproved new drugs pursuant to the FD&C Act.	Flawless Beauty LLC
18 mei 2015	glutathione	II	Lack of Assurance of Sterility	Advanced Physician Solutions, Inc.
18 jul 2025	nicotinamide	II	Lack of Processing Controls.	AEQUITA PHARMACY
18 jul 2025	nicotinamide	II	Lack of Processing Controls.	AEQUITA PHARMACY
18 jul 2025	nicotinamide	II	Lack of Processing Controls.	AEQUITA PHARMACY
18 jul 2025	nicotinamide	II	Lack of Processing Controls.	AEQUITA PHARMACY
18 jul 2025	nicotinamide	II	Lack of Processing Controls.	AEQUITA PHARMACY
18 jul 2025	nicotinamide	II	Lack of Processing Controls.	AEQUITA PHARMACY
18 jul 2025	nicotinamide	II	Lack of Processing Controls.	AEQUITA PHARMACY
18 apr 2017	glutathione	II	Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.	Key Pharmacy and Compounding Center
17 nov 2016	nicotinamide	II	Lack of Assurance of Sterility	Tri-Coast Pharmacy
17 nov 2016	nicotinamide	II	Lack of Assurance of Sterility	Tri-Coast Pharmacy
17 nov 2016	nicotinamide	II	Lack of Assurance of Sterility	Tri-Coast Pharmacy
17 nov 2016	nicotinamide	II	Lack of Assurance of Sterility	Tri-Coast Pharmacy
17 nov 2016	nicotinamide	II	Lack of Assurance of Sterility	Tri-Coast Pharmacy
17 nov 2016	glutathione	II	Lack of Assurance of Sterility	Tri-Coast Pharmacy
17 nov 2016	nicotinamide	II	Lack of Assurance of Sterility	Tri-Coast Pharmacy
17 nov 2016	nicotinamide	II	Lack of Assurance of Sterility	Tri-Coast Pharmacy
17 mei 2018	glutathione	II	Lack of sterility assurance.	Guardian Pharmacy Services
17 mei 2018	glutathione	II	Lack of sterility assurance.	Guardian Pharmacy Services
17 mei 2018	glutathione	II	Lack of sterility assurance.	Guardian Pharmacy Services
17 mei 2016	glutathione	II	Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.	Well Care Compounding Pharmacy
17 mei 2016	glutathione	II	Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.	Well Care Compounding Pharmacy
17 dec 2018	nicotinamide	II	Lack of sterility assurance.	Promise Pharmacy, LLC
17 dec 2018	glutathione	II	Lack of sterility assurance.	Promise Pharmacy, LLC
17 dec 2018	nicotinamide	II	Lack of sterility assurance.	Promise Pharmacy, LLC
17 dec 2018	nicotinamide	II	Lack of sterility assurance.	Promise Pharmacy, LLC
17 dec 2018	nicotinamide	II	Lack of sterility assurance.	Promise Pharmacy, LLC
16 okt 2015	glutathione	II	Lack of Assurance of Sterility	Downing Labs, LLC
16 mrt 2017	bimatoprost	III	Failed Impurities/Degradation Specifications	Allergan Sales, LLC
15 mrt 2021	semaglutide	II	CGMP Deviations: Intermittent exposure to temperature excursion during storage.	Cardinal Health Inc.
15 mei 2015	glutathione	II	Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection	Montana Compounding Pharmacy
15 mei 2015	glutathione	II	Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection	Montana Compounding Pharmacy
15 jan 2020	glutathione	II	Lack of Assurance of Sterility	Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
15 aug 2017	glutathione	II	Lack of Assurance of Sterility.	Bella Pharmaceuticals, Inc.
13 mei 2016	nicotinamide	II	Lack of Assurance of Sterility	Medaus, Inc.
13 mei 2016	glutathione	II	Lack of Assurance of Sterility	Medaus, Inc.
13 aug 2021	glutathione	II	Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
13 aug 2021	glutathione	II	Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
12 sep 2019	glutathione	II	Lack of Assurance of Sterility	KRS Global Biotechnology, Inc
12 dec 2014	glutathione	II	Incorrect Product Formulation: An incorrect gas was used to remove the oxygen from the vial.	Right Value Drug Stores, Inc.
12 aug 2019	glutathione	II	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
12 aug 2019	glutathione	II	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
12 aug 2019	glutathione	II	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
10 sep 2018	glutathione	II	Lack of Assurance of Sterility	Pharm D Solutions, LLC
10 feb 2017	nicotinamide	II	Lack of Assurance of Sterility: There are also CGMP Deviations.	Synergy Rx
10 feb 2017	nicotinamide	II	Lack of Assurance of Sterility: There are also CGMP Deviations.	Synergy Rx
10 feb 2017	nicotinamide	II	Lack of Assurance of Sterility: There are also CGMP Deviations.	Synergy Rx
1 nov 2013	glutathione	II	Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.	Natures Pharmacy & Compounding Center
1 nov 2013	glutathione	II	Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.	Natures Pharmacy & Compounding Center
1 nov 2013	glutathione	II	Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.	Natures Pharmacy & Compounding Center
1 nov 2013	glutathione	II	Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.	Natures Pharmacy & Compounding Center

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