Flux des rappels
Rappels récents de la FDA
Pour les médicaments, dispositifs, compléments et cosmétiques. Les plus récents en premier. Source : openFDA enforcement.
affichage de 100 sur 100
| Date ↓ | Substance | Classe | Motif | Fabricant |
|---|---|---|---|---|
| 9 mai 2022 | nicotinamide | II | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| 9 mai 2022 | nicotinamide | II | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| 9 mai 2022 | glutathione | II | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| 8 avr. 2019 | glutathione | II | Lack of assurance of sterility for injectables and solutions intended to be sterile. | Customceutical Compounding |
| 7 mars 2022 | glutathione | II | Lack of Assurance of Sterility | TMC Acquisition LLC dba Tailor Made Compounding |
| 7 mars 2022 | glutathione | II | Lack of Assurance of Sterility | TMC Acquisition LLC dba Tailor Made Compounding |
| 6 oct. 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 oct. 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 sept. 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 juil. 2025 | glutathione | II | Lack of Assurance of Sterility | GenoGenix LLC |
| 30 juil. 2025 | copper peptide | II | Lack of Assurance of Sterility | GenoGenix LLC |
| 30 juil. 2025 | glutathione | II | Lack of Assurance of Sterility | GenoGenix LLC |
| 29 avr. 2014 | glutathione | II | Marketed Without An Approved NDA/ANDA: Parenteral product is labeled for use as an antidote. | Flawless Beauty LLC |
| 29 avr. 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 avr. 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 avr. 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 juin 2019 | glutathione | II | Lack of Assurance of Sterility. | First Pharma Associates LLC dba Riverpoint Pharmacy |
| 25 juin 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 juin 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 mai 2022 | nicotinamide | II | Lack of Assurance of Sterility | US Specialty Formulations LLC |
| 24 juil. 2015 | glutathione | II | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | JD & SN Inc., dba Moses Lake Professional Pharmacy |
| 24 juil. 2015 | glutathione | II | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | JD & SN Inc., dba Moses Lake Professional Pharmacy |
| 23 mai 2019 | nicotinamide | II | Lack of Sterility Assurance. | Pharm D Solutions, LLC |
| 23 août 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 août 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 mars 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 déc. 2022 | nicotinamide | II | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Pharmacy Innovations |
| 22 déc. 2022 | nicotinamide | II | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Pharmacy Innovations |
| 22 déc. 2022 | glutathione | II | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Pharmacy Innovations |
| 21 sept. 2016 | glutathione | II | Lack of Assurance of Sterility | Wells Pharmacy Network LLC |
| 21 août 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 juin 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 juin 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 janv. 2019 | glutathione | II | Lack of sterility assurance. | Hiers Enterprises, LLC dba Northwest Compounding Pharmacy |
| 2 janv. 2019 | glutathione | II | Lack of sterility assurance. | Hiers Enterprises, LLC dba Northwest Compounding Pharmacy |
| 19 oct. 2017 | bimatoprost | III | Failed Impurities/Degradation Specifications. | Allergan Sales, LLC |
| 19 oct. 2015 | glutathione | II | Lack of Assurance of Sterility | Western Drug |
| 19 oct. 2015 | glutathione | II | Lack of Assurance of Sterility | Western Drug |
| 19 oct. 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 juin 2019 | glutathione | II | Lack of Assurance of Sterility | RXQ Compounding LLC |
| 19 juin 2019 | nicotinamide | II | Lack of Assurance of Sterility | RXQ Compounding LLC |
| 19 juin 2019 | glutathione | II | Lack of Assurance of Sterility | RXQ Compounding LLC |
| 19 janv. 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 janv. 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 janv. 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 janv. 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 janv. 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 mai 2015 | glutathione | II | Lack of Assurance of Sterility | Advanced Physician Solutions, Inc. |
| 18 juil. 2025 | nicotinamide | II | Lack of Processing Controls. | AEQUITA PHARMACY |
| 18 juil. 2025 | nicotinamide | II | Lack of Processing Controls. | AEQUITA PHARMACY |
| 18 juil. 2025 | nicotinamide | II | Lack of Processing Controls. | AEQUITA PHARMACY |
| 18 juil. 2025 | nicotinamide | II | Lack of Processing Controls. | AEQUITA PHARMACY |
| 18 juil. 2025 | nicotinamide | II | Lack of Processing Controls. | AEQUITA PHARMACY |
| 18 juil. 2025 | nicotinamide | II | Lack of Processing Controls. | AEQUITA PHARMACY |
| 18 juil. 2025 | nicotinamide | II | Lack of Processing Controls. | AEQUITA PHARMACY |
| 18 avr. 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 mai 2018 | glutathione | II | Lack of sterility assurance. | Guardian Pharmacy Services |
| 17 mai 2018 | glutathione | II | Lack of sterility assurance. | Guardian Pharmacy Services |
| 17 mai 2018 | glutathione | II | Lack of sterility assurance. | Guardian Pharmacy Services |
| 17 mai 2016 | glutathione | II | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Well Care Compounding Pharmacy |
| 17 mai 2016 | glutathione | II | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Well Care Compounding Pharmacy |
| 17 déc. 2018 | nicotinamide | II | Lack of sterility assurance. | Promise Pharmacy, LLC |
| 17 déc. 2018 | glutathione | II | Lack of sterility assurance. | Promise Pharmacy, LLC |
| 17 déc. 2018 | nicotinamide | II | Lack of sterility assurance. | Promise Pharmacy, LLC |
| 17 déc. 2018 | nicotinamide | II | Lack of sterility assurance. | Promise Pharmacy, LLC |
| 17 déc. 2018 | nicotinamide | II | Lack of sterility assurance. | Promise Pharmacy, LLC |
| 16 oct. 2015 | glutathione | II | Lack of Assurance of Sterility | Downing Labs, LLC |
| 16 mars 2017 | bimatoprost | III | Failed Impurities/Degradation Specifications | Allergan Sales, LLC |
| 15 mars 2021 | semaglutide | II | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. |
| 15 mai 2015 | glutathione | II | Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection | Montana Compounding Pharmacy |
| 15 mai 2015 | glutathione | II | Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection | Montana Compounding Pharmacy |
| 15 janv. 2020 | glutathione | II | Lack of Assurance of Sterility | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical |
| 15 août 2017 | glutathione | II | Lack of Assurance of Sterility. | Bella Pharmaceuticals, Inc. |
| 13 mai 2016 | nicotinamide | II | Lack of Assurance of Sterility | Medaus, Inc. |
| 13 mai 2016 | glutathione | II | Lack of Assurance of Sterility | Medaus, Inc. |
| 13 août 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 août 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 sept. 2019 | glutathione | II | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc |
| 12 déc. 2014 | glutathione | II | Incorrect Product Formulation: An incorrect gas was used to remove the oxygen from the vial. | Right Value Drug Stores, Inc. |
| 12 août 2019 | glutathione | II | Lack of Assurance of Sterility | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy |
| 12 août 2019 | glutathione | II | Lack of Assurance of Sterility | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy |
| 12 août 2019 | glutathione | II | Lack of Assurance of Sterility | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy |
| 10 sept. 2018 | glutathione | II | Lack of Assurance of Sterility | Pharm D Solutions, LLC |
| 10 févr. 2017 | nicotinamide | II | Lack of Assurance of Sterility: There are also CGMP Deviations. | Synergy Rx |
| 10 févr. 2017 | nicotinamide | II | Lack of Assurance of Sterility: There are also CGMP Deviations. | Synergy Rx |
| 10 févr. 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 |
Classe I = probabilité raisonnable de préjudice grave · Classe II = temporaire ou réversible · Classe III = peu susceptible de causer un préjudice.