Perfil del fabricante
Best Choice
Compañía farmacéutica2 productos registrados
2
productos registrados
214.547
notificaciones totales
81
retiradas registradas
67,4%
graves en total
Productos
mostrando 2 de 2
| Producto | Aprobado | Notificaciones ↓ | Señal principal | Retiradas |
|---|---|---|---|---|
| 1972 | 195.250 | Reacción relacionada con la infusión | 49 | |
| — | 19.297 | Reacción relacionada con la infusión | 32 |
Historial de retiradas · 29 registradas
| Fecha | Clase | Motivo | Empresa |
|---|---|---|---|
| 26 mar 2025 | II | CGMP Deviations; detection of Nitrosamine Drug Substance-Related Impurities (NDSRI), N-nitroso-desmethyl-diphenhydramine (n-dph), above the FDA Recommended Intake Limit | Chattem Inc |
| 4 mar 2025 | II | CGMP Deviations: Nitrosamine Drug Substance Related Issue impurity above the daily acceptable intake limit defined by the Food and Drug Administration. | Chattem Inc |
| 12 dic 2024 | III | Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID. | Akron Pharma, Inc. |
| 12 dic 2024 | III | Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID. | Akron Pharma, Inc. |
| 12 dic 2024 | III | Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID. | Akron Pharma, Inc. |
| 28 abr 2023 | II | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. | Central Admixture Pharmacy Services, Inc. |
| 27 dic 2022 | II | Lack of sterility assurance | Sentara Infusion Services |
| 23 jun 2022 | II | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. |
| 13 abr 2022 | II | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office |
| 24 ene 2022 | II | cGMP deviations | Ultra Seal Corporation |
| 15 mar 2021 | II | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. |
| 24 jun 2019 | II | Microbial Contamination of Non-sterile Products: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). | H J Harkins Company Inc dba Pharma Pac |
| 12 jun 2019 | II | Lack of Assurance of Sterility | Infusion Options, Inc. |
| 31 may 2019 | II | cGMP Deviations: Products may have microbial contamination. | Geritrex, LLC |
| 21 may 2019 | II | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). | Torrent Pharma Inc |
| 21 may 2019 | II | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). | Torrent Pharma Inc |
| 9 feb 2018 | II | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. | American Pharmaceutical Ingredients LLC |
| 30 ago 2017 | II | CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia. | Mid Valley Pharmaceutical |
| 30 ago 2017 | II | CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia. | Mid Valley Pharmaceutical |
| 5 ene 2017 | III | Subpotent | InnovaGel |
| 28 may 2015 | II | Lack of Assurance of Sterility: Sterility of product is not assured. | Lincare, Inc. |
| 6 mar 2015 | II | Microbial Contamination of a Non-Sterile Product: Kit component is contaminated with Burkholderia multivorans. | Fusion Pharmaceuticals, LLC |
| 26 dic 2014 | II | Lack of sterility assurance. | Walgreens Infusion Services |
| 25 abr 2014 | III | Presence of Precipitate; small amounts of diphenhydramine precipitated out of solution | Prestige Brands Holdings |
| 15 abr 2014 | III | Presence of Precipitate: Small amounts of diphenydramine and mannitol precipitated out of solution. | P&L Developments, LLC |
| 2 jul 2013 | II | Labeling: Label Mixup; diphenhydrAMINE HCl, Tablet, 25 mg may be potentially mislabeled as ATORVASTATIN CALCIUM, Tablet, 40 mg, NDC 00378212177, Pedigree: AD33897_10, EXP: 5/9/2014; ATORVASTATIN CALCIUM, Tablet, 10 mg, NDC 00378201577, Pedigree: W002774, EXP: 6/6/2014; PRENATAL MULTIVITAMIN/ MULTIMINERAL, Tablet, NDC 51991056601, Pedigree: W003511, EXP: 6/21/2014; VENLAFAXINE, Tablet, 25 mg | Aidapak Services, LLC |
| 18 jun 2013 | II | Presence of Foreign Substance: The products are being recalled because they may contain foreign substances. | Novartis Consumer Health |
| 29 may 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 |
| 25 may 2012 | II | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. | Franck's Lab Inc., d.b.a. Franck's Compounding Lab |
Clase I = probabilidad razonable de daño grave · Clase II = temporal o reversible · Clase III = improbable que cause daño.
Estado de registro
Algunos productos de Best Choice no están registrados por la FDA para uso humano. Para las sustancias no registradas (péptidos, SARM sin registro humano) no existe ningún proveedor legítimo para uso humano. La ausencia de una vía de aprovisionamiento es la información de seguridad.