Herstellerprofil
Clinical Solutions Wholesale, LLC
Pharmaunternehmen2 erfasste Produkte
2
erfasste Produkte
125.251
Meldungen insgesamt
30
dokumentierte Rückrufe
51,6%
schwerwiegend insgesamt
Produkte
2 von 2 angezeigt
| Produkt | Zugelassen | Meldungen ↓ | Top-Signal | Rückrufe |
|---|---|---|---|---|
| 1996 | 123.005 | Unzureichende Schmerzbehandlung | 30 | |
| — | 2.246 | Abnormale Löslichkeit des Produkts | 0 |
Rückrufhistorie · 30 dokumentiert
| Datum | Klasse | Grund | Firma |
|---|---|---|---|
| 12. Juni 2026 | II | Crystallization; identified as Buprenorphine free base | Par Health USA, LLC |
| 13. März 2026 | II | Crystallization; identified as Buprenorphine free base | ENDO USA, Inc. |
| 20. Mai 2024 | II | Lack of Assurance of Sterility-The potential for incomplete crimp seals. | Pfizer Inc. |
| 3. Mai 2023 | II | CGMP Deviations | SUN PHARMACEUTICAL INDUSTRIES INC |
| 15. Feb. 2023 | III | Failed Impurities/Degradation Specifications: Out of specification for related substance 10-hydroxy buprenorphine N-Oxide results generated at the 18-month stability timepoint. | AVEVA Drug Delivery Systems, Inc. |
| 15. Feb. 2023 | III | Failed Impurities/Degradation Specifications: Out of specification for related substance 10-hydroxy buprenorphine N-Oxide results generated at the 18-month stability timepoint. | AVEVA Drug Delivery Systems, Inc. |
| 22. Dez. 2022 | II | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Pharmacy Innovations |
| 18. Okt. 2022 | II | Presence of Foreign Substance | SUN PHARMACEUTICAL INDUSTRIES INC |
| 9. Nov. 2021 | II | Crystallization; identified as Buprenorphine free base | PAR Sterile Products LLC |
| 15. März 2021 | II | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. |
| 15. März 2021 | II | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. |
| 15. März 2021 | II | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. |
| 26. Feb. 2021 | II | Subpotent drug: Out of specification for assay of naloxone and buprenorphine (low) | Alvogen, Inc |
| 4. Sept. 2020 | II | Failed Stability Specifications: Below specification result for buprenorphine release rate. | Teva Pharmaceuticals USA |
| 14. Aug. 2020 | II | Sub-potent Drug: Out-of-Specification assay results found at 3 month stability testing. | Hikma Pharmaceuticals USA Inc. |
| 10. März 2020 | II | Subpotent Drug | Matthew 7:25 Inc dba Thrive Pharmacy |
| 10. März 2020 | II | Subpotent Drug | Matthew 7:25 Inc dba Thrive Pharmacy |
| 29. Juni 2017 | III | Failed Impurities/Degradation Specifications: out of specification test results for related compounds largest unknown impurity. | Teva Pharmaceuticals USA |
| 29. Juni 2017 | III | Failed Impurities/Degradation Specifications: out of specification test results for related compounds largest unknown impurity. | Teva Pharmaceuticals USA |
| 28. Apr. 2017 | II | Crystallization: due to the presence of white, crystalline particulates, adhered to the side and bottom of the glass vials, which are comprised of principally dextrose and the buprenorphine active component. | PAR Sterile Products LLC |
| 7. Feb. 2017 | II | Failed Impurities/Degradation Specifications | Teva Pharmaceuticals USA |
| 26. Juli 2016 | II | Lack of Assurance of Sterility | Pharmacy Plus, Inc. dba Vital Care Compounder |
| 9. Sept. 2014 | II | Failed Impurities/Degradation Specification: Out of Specification results for pseudobuprenorphine impurity at the 9-month stability time point. | Hospira Inc. |
| 7. Apr. 2014 | II | Failed Impurities/Degradation Specifications: High out of specification impurity test results were obtained during stability testing. | Teva Pharmaceuticals USA |
| 7. Apr. 2014 | II | Failed Impurities/Degradation Specifications: High out of specification impurity test results were obtained during stability testing. | Teva Pharmaceuticals USA |
| 26. Juli 2013 | II | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance | Beacon Hill Medical Pharmacy, P.C. |
| 2. Juli 2013 | II | Labeling: Label Mixup: BUPRENORPHINE HCL SL, Tablet, 2 mg may be potentially mislabeled as one of the following drugs: DOCUSATE SODIUM, Capsule, 250 mg, NDC 00904789159, Pedigree: AD37072_4, EXP: 5/13/2014; MAGNESIUM CHLORIDE DR, Tablet, 64 mg, NDC 00904791152, Pedigree: AD54510_1, EXP: 2/28/2014. | Aidapak Services, LLC |
| 29. Mai 2013 | II | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Lowlite Investments, Inc. D/B/A Olympia Pharmacy |
| 10. Apr. 2013 | II | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. | FVS Holdings, Inc. dba. Green Valley Drugs |
| 25. März 2013 | II | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance | Pallimed Solutions |
Klasse I = begründete Wahrscheinlichkeit schwerwiegender Schäden · Klasse II = vorübergehend oder reversibel · Klasse III = Schaden unwahrscheinlich.
Registrierungsstatus
Einige Produkte von Clinical Solutions Wholesale, LLC 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.