Profil du fabricant
Alembic Pharmaceuticals Limited
Société pharmaceutique8 produits suivis
8
produits suivis
283 448
total des notifications
19
rappels enregistrés
66,7%
graves au total
Produits
affichage de 8 sur 8
| Produit | Approuvé | Notifications ↓ | Signal principal | Rappels |
|---|---|---|---|---|
| 2010 | 78 131 | anémie hémorragique | 5 | |
| — | 69 814 | Réaction médicamenteuse avec éosinophilie et symptômes systémiques | 0 | |
| — | 59 849 | Infection des voies respiratoires inférieures | 0 | |
| 2009 | 41 144 | hémangiome rénal | 0 | |
| 1987 | 13 393 | Dégénérescence maculaire | 13 | |
| 2011 | 9 105 | rêves anormaux | 0 | |
| — | 8 068 | augmentation de la pression intraoculaire | 0 | |
| 1996 | 3 944 | douleur au site de perfusion | 1 |
Historique des rappels · 19 enregistrés
| Date | Classe | Motif | Fabricant |
|---|---|---|---|
| 17 févr. 2026 | II | Defective container; inadequately sealed blister packaging. | The Harvard Drug Group LLC |
| 16 déc. 2025 | III | Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit. | Alembic Pharmaceuticals Limited |
| 10 oct. 2025 | III | Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit. | Alembic Pharmaceuticals Limited |
| 25 juil. 2025 | II | CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit. | Alembic Pharmaceuticals Limited |
| 9 mai 2025 | II | Presence of Foreign Tablets/Capsules; customer complaint found one Tadalafil 5mg tablet inside a sealed 500-count bottle of Celecoxib 200mg capsule | Alembic Pharmaceuticals Limited |
| 12 déc. 2024 | II | CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit | Ascend Laboratories, LLC |
| 12 déc. 2024 | II | CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit | Ascend Laboratories, LLC |
| 30 août 2024 | II | Subpotent Drug | Glenmark Pharmaceuticals Inc., USA |
| 14 mars 2023 | II | CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit. | Ascend Laboratories, LLC |
| 14 mars 2023 | II | CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit. | Ascend Laboratories, LLC |
| 13 avr. 2022 | II | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office |
| 10 juin 2020 | II | Labeling: Label mix up: Bottles labeled as aripiprazole 2 mg, 30 count had aripiprazole 5 mg tablets, 100 count. | Alembic Pharmaceuticals Limited |
| 18 juil. 2016 | II | Penicillin Cross Contamination | GlaxoSmithKline, LLC |
| 18 juil. 2016 | II | Penicillin Cross Contamination | GlaxoSmithKline, LLC |
| 18 juil. 2016 | II | Penicillin Cross Contamination | GlaxoSmithKline, LLC |
| 13 août 2015 | II | Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin and foreign substances during manufacturing process. | GlaxoSmithKline, LLC. |
| 13 août 2015 | II | Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin and foreign substances during manufacturing process. | GlaxoSmithKline, 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 |
| 5 nov. 2012 | II | Defective container; damaged bottles could allow moisture to get into the bottle and thus may impair the quality of the product | Boehringer Ingelheim Roxane Inc |
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 Alembic Pharmaceuticals Limited 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.