Profil du fabricant
Allergan, Inc.
Société pharmaceutique14 produits suivis
14
produits suivis
339 204
total des notifications
61
rappels enregistrés
44,3%
graves au total
Produits
affichage de 14 sur 14
| Produit | Approuvé | Notifications ↓ | Signal principal | Rappels |
|---|---|---|---|---|
| 1955 | 188 016 | Infection à cytomégalovirus | 33 | |
| 1991 | 75 403 | Utilisation multiple d'un produit à usage unique | 0 | |
| 2012 | 25 697 | flatulence | 1 | |
| 1955 | 10 056 | Endophtalmie | 8 | |
| 2015 | 8 903 | akathisie | 1 | |
| — | 6 551 | augmentation de la pression intraoculaire | 5 | |
| 2009 | 5 952 | Fibromyalgie | 0 | |
| 2019 | 5 632 | Migraine | 0 | |
| — | 3 150 | Aménorrhée | 0 | |
| 2015 | 2 902 | Médicament contre-indiqué prescrit | 0 | |
| — | 2 372 | Hyperémie sclérale | 0 | |
| 2013 | 1 881 | syndrome de chevauchement | 0 | |
| 2003 | 1 747 | Syndrome toxique du segment antérieur | 13 | |
| — | 942 | douleur à la paupière | 0 |
Historique des rappels · 39 enregistrés
| Date | Classe | Motif | Fabricant |
|---|---|---|---|
| 18 mai 2026 | III | Failed Stability Specifications | AbbVie Inc. |
| 26 avr. 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 août 2022 | II | Defective Container: Product has incomplete induction seals. | Akorn, Inc |
| 13 avr. 2022 | II | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office |
| 22 déc. 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 mars 2021 | II | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. |
| 15 mars 2021 | II | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. |
| 5 juin 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 juil. 2019 | III | Labeling: Missing label; Product complaints reported missing bottle label. | Lupin Pharmaceuticals Inc. |
| 17 déc. 2018 | II | Lack of sterility assurance. | Promise Pharmacy, LLC |
| 17 déc. 2018 | II | Lack of sterility assurance. | Promise Pharmacy, LLC |
| 17 déc. 2018 | II | Lack of sterility assurance. | Promise Pharmacy, LLC |
| 17 déc. 2018 | II | Lack of sterility assurance. | Promise Pharmacy, LLC |
| 17 déc. 2018 | II | Lack of sterility assurance. | Promise Pharmacy, LLC |
| 18 oct. 2018 | III | Presence of precipitate | Promise Pharmacy LLC |
| 24 juil. 2018 | II | Defective Container: Tamper Evident foil seal not completely intact. | Morton Grove Pharmaceuticals, Inc. |
| 30 avr. 2018 | II | CGMP Deviations | Mylan Pharmaceuticals Inc. |
| 30 avr. 2018 | II | CGMP Deviations | Mylan Pharmaceuticals Inc. |
| 30 avr. 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 mai 2017 | II | Failed Impurities/Degradation Specifications: stability testing results did not meet the specification for impurities. | Allergan Sales, LLC |
| 28 mars 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 août 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 août 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 juil. 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 mai 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 |
Classe I = probabilité raisonnable de préjudice grave · Classe II = temporaire ou réversible · Classe III = peu susceptible de causer un préjudice.
Statut d'enregistrement
Certains produits de Allergan, Inc. ne sont pas enregistrés auprès de la FDA pour un usage humain. Pour les substances non enregistrées (peptides, SARMs sans enregistrement humain), aucun fournisseur légitime à usage humain n'existe. L'absence de filière d'approvisionnement est l'information de sécurité.