Perfil del fabricante
Allergan, Inc.
Compañía farmacéutica14 productos registrados
14
productos registrados
339.204
notificaciones totales
61
retiradas registradas
44,3%
graves en total
Productos
mostrando 14 de 14
| Producto | Aprobado | Notificaciones ↓ | Señal principal | Retiradas |
|---|---|---|---|---|
| 1955 | 188.016 | Infección por citomegalovirus | 33 | |
| 1991 | 75.403 | Uso múltiple de producto de un solo uso | 0 | |
| 2012 | 25.697 | flatulencia | 1 | |
| 1955 | 10.056 | Endoftalmitis | 8 | |
| 2015 | 8903 | acatisia | 1 | |
| — | 6551 | aumento de la presión intraocular | 5 | |
| 2009 | 5952 | Fibromialgia | 0 | |
| 2019 | 5632 | Migraña | 0 | |
| — | 3150 | Amenorrea | 0 | |
| 2015 | 2902 | Medicamento contraindicado prescrito | 0 | |
| — | 2372 | Hiperemia escleral | 0 | |
| 2013 | 1881 | Síndrome de solapamiento | 0 | |
| 2003 | 1747 | Síndrome tóxico del segmento anterior | 13 | |
| — | 942 | dolor en el párpado | 0 |
Historial de retiradas · 39 registradas
| Fecha | Clase | Motivo | Empresa |
|---|---|---|---|
| 18 may 2026 | III | Failed Stability Specifications | AbbVie Inc. |
| 26 abr 2023 | II | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. |
| 7 oct 2022 | II | Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile. | Pharmacy Plus, Inc. dba Vital Care Compounder |
| 1 ago 2022 | II | Defective Container: Product has incomplete induction seals. | Akorn, Inc |
| 13 abr 2022 | II | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office |
| 22 dic 2021 | III | Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration. | Lupin Pharmaceuticals Inc. |
| 20 oct 2021 | III | Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration. | Lupin Pharmaceuticals Inc. |
| 15 mar 2021 | II | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. |
| 15 mar 2021 | II | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. |
| 5 jun 2020 | III | Discoloration: Out of Specification (OOS) result for APHA Color Test. | Akorn, Inc. |
| 17 oct 2019 | III | Labeling: Incorrect or missing package insert. | Sandoz Inc |
| 23 sept 2019 | II | Failed Impurities/Degradation Specifications - failed specs for Prednisolone Impurity 14 | Morton Grove Pharmaceuticals, Inc. |
| 6 sept 2019 | III | Failed Impurities/Degradation Specifications:OOS for unknown impurity. | Mylan Pharmaceuticals Inc. |
| 11 jul 2019 | III | Labeling: Missing label; Product complaints reported missing bottle label. | Lupin Pharmaceuticals Inc. |
| 17 dic 2018 | II | Lack of sterility assurance. | Promise Pharmacy, LLC |
| 17 dic 2018 | II | Lack of sterility assurance. | Promise Pharmacy, LLC |
| 17 dic 2018 | II | Lack of sterility assurance. | Promise Pharmacy, LLC |
| 17 dic 2018 | II | Lack of sterility assurance. | Promise Pharmacy, LLC |
| 17 dic 2018 | II | Lack of sterility assurance. | Promise Pharmacy, LLC |
| 18 oct 2018 | III | Presence of precipitate | Promise Pharmacy LLC |
| 24 jul 2018 | II | Defective Container: Tamper Evident foil seal not completely intact. | Morton Grove Pharmaceuticals, Inc. |
| 30 abr 2018 | II | CGMP Deviations | Mylan Pharmaceuticals Inc. |
| 30 abr 2018 | II | CGMP Deviations | Mylan Pharmaceuticals Inc. |
| 30 abr 2018 | II | CGMP Deviations | Mylan Pharmaceuticals Inc. |
| 16 nov 2017 | II | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. | KRS Global Biotechnology, Inc |
| 1 may 2017 | II | Failed Impurities/Degradation Specifications: stability testing results did not meet the specification for impurities. | Allergan Sales, LLC |
| 28 mar 2017 | III | Failed Stability Specifications | Teva Pharmaceuticals USA |
| 20 sept 2016 | II | Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters | Leiter's Compounding |
| 12 sept 2015 | II | Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance. | US Compounding Inc |
| 24 ago 2015 | II | Presence of Particulate Matter: Due to customer complaints of small black particles, identified as part of the ointment tube cap, generated by the action of unscrewing the cap from the aluminum tube and potentially introducing the particle into the product. | Allergan Sales, LLC |
| 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 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 oct 2014 | 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 |
| 27 ago 2014 | II | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance. | Martin Avenue Pharmacy, Inc. |
| 19 oct 2013 | 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 |
| 2 jul 2013 | II | Labeling: Label Mixup; prednisoLONE, Tablet, 5 mg may be potentially mislabeled as ASPIRIN/ER DIPYRIDAMOLE, Capsule, 25 mg/200 mg, NDC 00597000160, Pedigree: W003644, EXP: 8/24/2013. | Aidapak Services, LLC |
| 21 may 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 |
Clase I = probabilidad razonable de daño grave · Clase II = temporal o reversible · Clase III = improbable que cause daño.
Estado de registro
Algunos productos de Allergan, Inc. no están registrados por la FDA para uso humano. Para las sustancias no registradas (péptidos, SARM sin registro humano) no existe ningún proveedor legítimo para uso humano. La ausencia de una vía de aprovisionamiento es la información de seguridad.