Profil du fabricant
Clinical Solutions Wholesale, LLC
Société pharmaceutique2 produits suivis
2
produits suivis
125 251
total des notifications
30
rappels enregistrés
51,6%
graves au total
Produits
affichage de 2 sur 2
| Produit | Approuvé | Notifications ↓ | Signal principal | Rappels |
|---|---|---|---|---|
| 1996 | 123 005 | Analgesie inadéquate | 30 | |
| — | 2 246 | solubilité anormale du produit | 0 |
Historique des rappels · 30 enregistrés
| Date | Classe | Motif | Fabricant |
|---|---|---|---|
| 12 juin 2026 | II | Crystallization; identified as Buprenorphine free base | Par Health USA, LLC |
| 13 mars 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 févr. 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 févr. 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 déc. 2022 | II | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Pharmacy Innovations |
| 18 oct. 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 mars 2021 | II | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. |
| 15 mars 2021 | II | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. |
| 15 mars 2021 | II | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. |
| 26 févr. 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 août 2020 | II | Sub-potent Drug: Out-of-Specification assay results found at 3 month stability testing. | Hikma Pharmaceuticals USA Inc. |
| 10 mars 2020 | II | Subpotent Drug | Matthew 7:25 Inc dba Thrive Pharmacy |
| 10 mars 2020 | II | Subpotent Drug | Matthew 7:25 Inc dba Thrive Pharmacy |
| 29 juin 2017 | III | Failed Impurities/Degradation Specifications: out of specification test results for related compounds largest unknown impurity. | Teva Pharmaceuticals USA |
| 29 juin 2017 | III | Failed Impurities/Degradation Specifications: out of specification test results for related compounds largest unknown impurity. | Teva Pharmaceuticals USA |
| 28 avr. 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 févr. 2017 | II | Failed Impurities/Degradation Specifications | Teva Pharmaceuticals USA |
| 26 juil. 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 avr. 2014 | II | Failed Impurities/Degradation Specifications: High out of specification impurity test results were obtained during stability testing. | Teva Pharmaceuticals USA |
| 7 avr. 2014 | II | Failed Impurities/Degradation Specifications: High out of specification impurity test results were obtained during stability testing. | Teva Pharmaceuticals USA |
| 26 juil. 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 juil. 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 avr. 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 mars 2013 | II | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance | Pallimed Solutions |
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 Clinical Solutions Wholesale, LLC 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.