Fabrikant-profiel
Alembic Pharmaceuticals Limited
Farmaceutisch bedrijf8 producten gevolgd
8
producten gevolgd
283.448
totaal meldingen
19
recalls geregistreerd
66,7%
ernstig algeheel
Producten
8 van 8 getoond
| Product | Goedgekeurd | Meldingen ↓ | Top signaal | Recalls |
|---|---|---|---|---|
| 2010 | 78.131 | bloedarmoede door bloedverlies | 5 | |
| — | 69.814 | Medicijnreactie met eosinofilie en systemische symptomen | 0 | |
| — | 59.849 | Infectie van de lagere luchtwegen | 0 | |
| 2009 | 41.144 | hemangioom nier | 0 | |
| 1987 | 13.393 | Maculadegeneratie | 13 | |
| 2011 | 9.105 | abnormale dromen | 0 | |
| — | 8.068 | verhoogde intraoculaire druk | 0 | |
| 1996 | 3.944 | pijn op de infusieplaats | 1 |
Recall-geschiedenis · 19 geregistreerd
| Datum | Klasse | Reden | Bedrijf |
|---|---|---|---|
| 17 feb 2026 | II | Defective container; inadequately sealed blister packaging. | The Harvard Drug Group LLC |
| 16 dec 2025 | III | Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit. | Alembic Pharmaceuticals Limited |
| 10 okt 2025 | III | Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit. | Alembic Pharmaceuticals Limited |
| 25 jul 2025 | II | CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit. | Alembic Pharmaceuticals Limited |
| 9 mei 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 dec 2024 | II | CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit | Ascend Laboratories, LLC |
| 12 dec 2024 | II | CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit | Ascend Laboratories, LLC |
| 30 aug 2024 | II | Subpotent Drug | Glenmark Pharmaceuticals Inc., USA |
| 14 mrt 2023 | II | CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit. | Ascend Laboratories, LLC |
| 14 mrt 2023 | II | CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit. | Ascend Laboratories, LLC |
| 13 apr 2022 | II | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office |
| 10 jun 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 jul 2016 | II | Penicillin Cross Contamination | GlaxoSmithKline, LLC |
| 18 jul 2016 | II | Penicillin Cross Contamination | GlaxoSmithKline, LLC |
| 18 jul 2016 | II | Penicillin Cross Contamination | GlaxoSmithKline, LLC |
| 13 aug 2015 | II | Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin and foreign substances during manufacturing process. | GlaxoSmithKline, LLC. |
| 13 aug 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 |
Class I = redelijke kans op ernstige schade · Class II = tijdelijk of omkeerbaar · Class III = onwaarschijnlijk schadelijk.
Registratiestatus
Sommige producten van Alembic Pharmaceuticals Limited zijn niet FDA-geregistreerd voor humaan gebruik. Voor ongeregistreerde stoffen (peptiden, SARMs zonder humane registratie) bestaat geen legitieme leverancier voor humaan gebruik. Het ontbreken van een inkooproute is de veiligheidsinformatie.