Fabrikant-profiel
American Health Packaging
Farmaceutisch bedrijf9 producten gevolgd
9
producten gevolgd
305.146
totaal meldingen
58
recalls geregistreerd
81,2%
ernstig algeheel
Producten
9 van 9 getoond
| Product | Goedgekeurd | Meldingen ↓ | Top signaal | Recalls |
|---|---|---|---|---|
| 1968 | 88.112 | Colitis ulcerosa | 2 | |
| 1980 | 75.807 | Tardieve dyskinesie | 12 | |
| 1995 | 38.413 | lage bloedsuiker | 21 | |
| — | 31.032 | Afstoting nierentransplantaat | 3 | |
| 1965 | 20.833 | complicatie van sedatie | 0 | |
| — | 19.587 | Teruggeroepen product | 0 | |
| 1998 | 15.829 | Virale mutatie geïdentificeerd | 2 | |
| 2009 | 12.295 | trombose in apparaat | 3 | |
| 1978 | 3.238 | hypernatriëmie | 15 |
Recall-geschiedenis · 50 geregistreerd
| Datum | Klasse | Reden | Bedrijf |
|---|---|---|---|
| 23 mei 2025 | II | Presence of foreign tablets/capsules. | Teva Pharmaceuticals USA, Inc |
| 5 mrt 2025 | II | Failed Dissolution Specifications | Golden State Medical Supply Inc. |
| 25 feb 2025 | II | Failed Dissolution Specifications - low dissolution results | MYLAN PHARMACEUTICALS INC |
| 3 sep 2024 | II | Failed Dissolution Specifications | Ascend Laboratories, LLC |
| 18 jan 2024 | III | Misprint on tablet | Dr. Reddy's Laboratories, Inc. |
| 18 jan 2024 | III | Misprint on tablet | Dr. Reddy's Laboratories, Inc. |
| 6 apr 2023 | II | CGMP deviations. | PD-Rx Pharmaceuticals, Inc. |
| 23 mrt 2023 | II | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Preferred Pharmaceuticals, Inc. |
| 23 mrt 2023 | II | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Preferred Pharmaceuticals, Inc. |
| 20 mrt 2023 | II | cGMP Deviations | RemedyRepack Inc. |
| 17 mrt 2023 | II | CGMP Deviations: recalling drug products following an FDA inspection. | Amerisource Health Services LLC |
| 17 mrt 2023 | II | CGMP Deviations: recalling drug products following an FDA inspection. | Amerisource Health Services LLC |
| 17 mrt 2023 | II | CGMP Deviations: recalling drug products following an FDA inspection. | Amerisource Health Services LLC |
| 16 mrt 2023 | II | CGMP Deviations | Northwind Pharmaceuticals LLC |
| 16 mrt 2023 | II | CGMP Deviations | Northwind Pharmaceuticals LLC |
| 13 mrt 2023 | II | cGMP deviations | Direct Rx |
| 13 mrt 2023 | II | cGMP deviations | Direct Rx |
| 13 mrt 2023 | II | cGMP deviations | Direct Rx |
| 7 feb 2023 | II | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. |
| 7 feb 2023 | II | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. |
| 7 feb 2023 | II | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. |
| 5 dec 2022 | II | Subpotent Drug: repackaged product was recalled by the manufacturer for subpotency. | RemedyRepack Inc. |
| 23 nov 2022 | II | Subpotent Drug | Heritage Pharmaceuticals Inc |
| 29 jun 2022 | II | CGMP Deviations | Glenmark Pharmaceuticals Inc., USA |
| 3 mei 2022 | III | Failed Dissolution Specifications: Nitrofurantoin Capsules recalled due to dissolution failure at 0-time of the repackaged lot. Drug release results were above specification at 0-time. | American Health Packaging |
| 12 apr 2022 | III | Subpotent Drug: Out of specification for assay. | American Health Packaging |
| 22 feb 2022 | II | Impurity failure at 0-time of the repackaged lot. | American Health Packaging |
| 20 dec 2021 | II | Failed Dissolution Specifications | American Health Packaging |
| 17 sep 2021 | II | Failed Dissolution Specifications: results were above specification. | American Health Packaging |
| 29 jul 2021 | II | Lack of Assurance of Sterility | Teva Pharmaceuticals USA |
| 12 mei 2021 | III | Failed Impurities/Degradation Specifications | American Health Packaging |
| 26 apr 2021 | II | Lack of Assurance of Sterility | Teva Pharmaceuticals USA |
| 15 mrt 2021 | II | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. |
| 15 feb 2021 | II | Chemical contamination; Unknown brown residue adhering to the inside of one vial. | Teva Pharmaceuticals USA |
| 10 feb 2021 | II | Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products. | Teva Pharmaceuticals USA |
| 10 feb 2021 | II | Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products. | Teva Pharmaceuticals USA |
| 7 jan 2021 | II | Failed Dissolution Specifications | American Health Packaging |
| 21 jul 2020 | I | Superpotent Drug | Ferring Pharmaceuticals Inc |
| 21 jul 2020 | I | Superpotent Drug | Ferring Pharmaceuticals Inc |
| 21 jul 2020 | I | Superpotent Drug | Ferring Pharmaceuticals Inc |
| 10 jun 2020 | III | Labeling Not Elsewhere Classified: The statement Pharmacist: Dispense with the accompanying Medication Guide was not included on the carton label. | American Health Packaging |
| 19 mei 2020 | II | Failed dissolution specification - dissolution results of 59% (spec. NLT 85%) at the 24 month time point (end of shelf life). | American Health Packaging |
| 7 feb 2020 | II | GMP Deviations: Product bottle may be absent of desiccant. | American Health Packaging |
| 7 feb 2020 | II | GMP Deviations: Product bottle may be absent of desiccant. | American Health Packaging |
| 27 jan 2020 | II | GMP Deviations: Product bottle may be absent of desiccant. | Teva Pharmaceuticals USA |
| 27 jan 2020 | II | GMP Deviations: Product bottle may be absent of desiccant. | Teva Pharmaceuticals USA |
| 4 dec 2019 | II | Failed Dissolution Specifications: Low out of specification results obtained during stability testing. | American Health Packaging |
| 20 nov 2019 | II | CGMP Deviations: Potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA. | American Health Packaging |
| 1 nov 2019 | II | CGMP Deviations: Presence of NDMA impurity detected in product. | American Health Packaging |
| 18 okt 2019 | II | Failed Dissolution Specification: Low out of specification dissolution results. | Mylan Pharmaceuticals Inc. |
Class I = redelijke kans op ernstige schade · Class II = tijdelijk of omkeerbaar · Class III = onwaarschijnlijk schadelijk.
Registratiestatus
Sommige producten van American Health Packaging 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.