Profil du fabricant
Bestmade Natural Products
Société pharmaceutique5 produits suivis
5
produits suivis
396 976
total des notifications
47
rappels enregistrés
53,3%
graves au total
Produits
Historique des rappels · 34 enregistrés
| Date | Classe | Motif | Fabricant |
|---|---|---|---|
| 17 mai 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 févr. 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 juin 2022 | II | CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled. | Plastikon Healthcare LLC |
| 7 juin 2022 | II | CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled. | Plastikon Healthcare LLC |
| 7 juin 2022 | II | CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled. | Plastikon Healthcare LLC |
| 7 juin 2022 | II | CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled. | Plastikon Healthcare LLC |
| 7 juin 2022 | II | CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled. | Plastikon Healthcare LLC |
| 7 juin 2022 | I | Microbial Contamination of Non-Sterile Products. | Plastikon Healthcare LLC |
| 7 juin 2022 | II | CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled. | Plastikon Healthcare LLC |
| 7 juin 2022 | I | Microbial Contamination of Non-Sterile Products. | Plastikon Healthcare LLC |
| 7 juin 2022 | I | Microbial Contamination of Non-Sterile Products | Plastikon Healthcare LLC |
| 7 juin 2022 | II | CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled. | Plastikon Healthcare LLC |
| 7 juin 2022 | I | Microbial Contamination of Non-Sterile Products. | Plastikon Healthcare LLC |
| 7 juin 2022 | II | CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled. | Plastikon Healthcare LLC |
| 24 mars 2022 | I | Microbial Contamination of Non-Sterile Products | Plastikon Healthcare LLC |
| 24 mars 2022 | I | Microbial Contamination of Non-Sterile Products | Plastikon Healthcare LLC |
| 24 mars 2022 | II | CGMP Deviations: Failure to properly investigate failed microbial testing. | Plastikon Healthcare LLC |
| 24 mars 2022 | II | CGMP Deviations: Failure to properly investigate failed microbial testing. | Plastikon Healthcare LLC |
| 22 févr. 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 mars 2021 | II | Failed Impurities/Degradation Specifications; out of specification for unknown impurity observed during 6 month stability testing | Akorn, Inc. |
| 23 juin 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 mars 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 mai 2017 | III | Failed Impurities/Degradation Specifications: Presence of an impurity peak that exceeds approved specification. | VistaPharm, Inc. |
| 8 janv. 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 mars 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 mars 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 janv. 2011 | III | Labeling: Correct Labeled Product Miscart/Mispack: The shipper label displayed "5 mL x 50," instead of "10 mL x 50," | VistaPharm, Inc. |
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 Bestmade Natural Products 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.