Herstellerprofil
American Health Packaging
Pharmaunternehmen9 erfasste Produkte
9
erfasste Produkte
305.146
Meldungen insgesamt
58
dokumentierte Rückrufe
81,2%
schwerwiegend insgesamt
Produkte
9 von 9 angezeigt
| Produkt | Zugelassen | Meldungen ↓ | Top-Signal | Rückrufe |
|---|---|---|---|---|
| 1968 | 88.112 | Colitis ulcerosa | 2 | |
| 1980 | 75.807 | Tardive Dyskinesie | 12 | |
| 1995 | 38.413 | Unterzuckerung | 21 | |
| — | 31.032 | Abstossung nach Nierentransplantation | 3 | |
| 1965 | 20.833 | Komplikation durch Sedierung | 0 | |
| — | 19.587 | Zurückgerufenes Produkt | 0 | |
| 1998 | 15.829 | Virusmutation identifiziert | 2 | |
| 2009 | 12.295 | Thrombose im Gerät | 3 | |
| 1978 | 3.238 | Hypernatriämie | 15 |
Rückrufhistorie · 50 dokumentiert
| Datum | Klasse | Grund | Firma |
|---|---|---|---|
| 23. Mai 2025 | II | Presence of foreign tablets/capsules. | Teva Pharmaceuticals USA, Inc |
| 5. März 2025 | II | Failed Dissolution Specifications | Golden State Medical Supply Inc. |
| 25. Feb. 2025 | II | Failed Dissolution Specifications - low dissolution results | MYLAN PHARMACEUTICALS INC |
| 3. Sept. 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. März 2023 | II | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Preferred Pharmaceuticals, Inc. |
| 23. März 2023 | II | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Preferred Pharmaceuticals, Inc. |
| 20. März 2023 | II | cGMP Deviations | RemedyRepack Inc. |
| 17. März 2023 | II | CGMP Deviations: recalling drug products following an FDA inspection. | Amerisource Health Services LLC |
| 17. März 2023 | II | CGMP Deviations: recalling drug products following an FDA inspection. | Amerisource Health Services LLC |
| 17. März 2023 | II | CGMP Deviations: recalling drug products following an FDA inspection. | Amerisource Health Services LLC |
| 16. März 2023 | II | CGMP Deviations | Northwind Pharmaceuticals LLC |
| 16. März 2023 | II | CGMP Deviations | Northwind Pharmaceuticals LLC |
| 13. März 2023 | II | cGMP deviations | Direct Rx |
| 13. März 2023 | II | cGMP deviations | Direct Rx |
| 13. März 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. Dez. 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. Juni 2022 | II | CGMP Deviations | Glenmark Pharmaceuticals Inc., USA |
| 3. Mai 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. Dez. 2021 | II | Failed Dissolution Specifications | American Health Packaging |
| 17. Sept. 2021 | II | Failed Dissolution Specifications: results were above specification. | American Health Packaging |
| 29. Juli 2021 | II | Lack of Assurance of Sterility | Teva Pharmaceuticals USA |
| 12. Mai 2021 | III | Failed Impurities/Degradation Specifications | American Health Packaging |
| 26. Apr. 2021 | II | Lack of Assurance of Sterility | Teva Pharmaceuticals USA |
| 15. März 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. Juli 2020 | I | Superpotent Drug | Ferring Pharmaceuticals Inc |
| 21. Juli 2020 | I | Superpotent Drug | Ferring Pharmaceuticals Inc |
| 21. Juli 2020 | I | Superpotent Drug | Ferring Pharmaceuticals Inc |
| 10. Juni 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. Mai 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. Dez. 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. |
Klasse I = begründete Wahrscheinlichkeit schwerwiegender Schäden · Klasse II = vorübergehend oder reversibel · Klasse III = Schaden unwahrscheinlich.
Registrierungsstatus
Einige Produkte von American Health Packaging sind nicht für die Anwendung am Menschen FDA-registriert. Für nicht registrierte Substanzen (Peptide, SARMs ohne Humanzulassung) existiert kein legitimer Anbieter für die Anwendung am Menschen. Das Fehlen eines Bezugswegs ist die Sicherheitsinformation.