Perfil del fabricante
Bestmade Natural Products
Compañía farmacéutica5 productos registrados
5
productos registrados
396.976
notificaciones totales
47
retiradas registradas
53,3%
graves en total
Productos
Historial de retiradas · 34 registradas
| Fecha | Clase | Motivo | Empresa |
|---|---|---|---|
| 17 may 2024 | III | Labeling: Incorrect Lot and/or Expiration Date: The carton has incorrect expiration of 2026-MAY*, whereas the correct expiration date, which is on the tablet bottle label, is 2025-APR. | GlaxoSmithKline LLC |
| 2 feb 2024 | II | Subpotent Drug: Out of specification for assay | Bausch Health Companies, Inc. |
| 30 sept 2022 | II | cGMP Deviations: Out of specification for assay of one of the preservative ingredients. | VistaPharm, Inc. |
| 7 jun 2022 | II | CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled. | Plastikon Healthcare LLC |
| 7 jun 2022 | II | CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled. | Plastikon Healthcare LLC |
| 7 jun 2022 | II | CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled. | Plastikon Healthcare LLC |
| 7 jun 2022 | II | CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled. | Plastikon Healthcare LLC |
| 7 jun 2022 | II | CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled. | Plastikon Healthcare LLC |
| 7 jun 2022 | I | Microbial Contamination of Non-Sterile Products. | Plastikon Healthcare LLC |
| 7 jun 2022 | II | CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled. | Plastikon Healthcare LLC |
| 7 jun 2022 | I | Microbial Contamination of Non-Sterile Products. | Plastikon Healthcare LLC |
| 7 jun 2022 | I | Microbial Contamination of Non-Sterile Products | Plastikon Healthcare LLC |
| 7 jun 2022 | II | CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled. | Plastikon Healthcare LLC |
| 7 jun 2022 | I | Microbial Contamination of Non-Sterile Products. | Plastikon Healthcare LLC |
| 7 jun 2022 | II | CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled. | Plastikon Healthcare LLC |
| 24 mar 2022 | I | Microbial Contamination of Non-Sterile Products | Plastikon Healthcare LLC |
| 24 mar 2022 | I | Microbial Contamination of Non-Sterile Products | Plastikon Healthcare LLC |
| 24 mar 2022 | II | CGMP Deviations: Failure to properly investigate failed microbial testing. | Plastikon Healthcare LLC |
| 24 mar 2022 | II | CGMP Deviations: Failure to properly investigate failed microbial testing. | Plastikon Healthcare LLC |
| 22 feb 2022 | II | Impurity failure at 0-time of the repackaged lot. | American Health Packaging |
| 1 nov 2021 | II | cGMP Deviations: Product manufactured with contaminated raw ingredient. | Precision Dose Inc. |
| 1 nov 2021 | II | cGMP Deviations: Product manufactured with contaminated raw ingredient. | Precision Dose Inc. |
| 8 mar 2021 | II | Failed Impurities/Degradation Specifications; out of specification for unknown impurity observed during 6 month stability testing | Akorn, Inc. |
| 23 jun 2020 | III | Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification. | VistaPharm, Inc. |
| 13 nov 2019 | II | CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API. | Precision Dose Inc. |
| 1 nov 2019 | II | CGMP Deviations: Presence of NDMA impurity detected in product. | American Health Packaging |
| 25 mar 2019 | II | Labeling: Incorrect or Missing Lot and/or Exp Date - the label contains an incorrect Exp Date. | Lohxa LLC |
| 21 sept 2017 | II | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. | Medline Industries Inc |
| 17 may 2017 | III | Failed Impurities/Degradation Specifications: Presence of an impurity peak that exceeds approved specification. | VistaPharm, Inc. |
| 8 ene 2016 | II | Defective Delivery System: Firm recalled Guaifenesin liquid and Guaifenesin DM liquid due incorrect dose markings on the dosing cups. | Perrigo Company PLC |
| 17 mar 2015 | II | Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole. | Akorn, Inc. |
| 14 nov 2014 | II | Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin. | Attix Pharmaceuticals |
| 21 mar 2013 | II | Labeling: Not Elsewhere Classified: This unit dose product is being recalled because the product's name includes the word "Children's" which is misleading since the 650 mg dose of acetaminophen contained within it, is an adult dose. | Precision Dose Inc. |
| 19 ene 2011 | III | Labeling: Correct Labeled Product Miscart/Mispack: The shipper label displayed "5 mL x 50," instead of "10 mL x 50," | VistaPharm, Inc. |
Clase I = probabilidad razonable de daño grave · Clase II = temporal o reversible · Clase III = improbable que cause daño.
Estado de registro
Algunos productos de Bestmade Natural Products 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.