Profil du fabricant
Best Choice
Société pharmaceutique2 produits suivis
2
produits suivis
214 547
total des notifications
81
rappels enregistrés
67,4%
graves au total
Produits
affichage de 2 sur 2
| Produit | Approuvé | Notifications ↓ | Signal principal | Rappels |
|---|---|---|---|---|
| 1972 | 195 250 | Réaction liée à la perfusion | 49 | |
| — | 19 297 | Réaction liée à la perfusion | 32 |
Historique des rappels · 29 enregistrés
| Date | Classe | Motif | Fabricant |
|---|---|---|---|
| 26 mars 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 mars 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 déc. 2024 | III | Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID. | Akron Pharma, Inc. |
| 12 déc. 2024 | III | Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID. | Akron Pharma, Inc. |
| 12 déc. 2024 | III | Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID. | Akron Pharma, Inc. |
| 28 avr. 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 déc. 2022 | II | Lack of sterility assurance | Sentara Infusion Services |
| 23 juin 2022 | II | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. |
| 13 avr. 2022 | II | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office |
| 24 janv. 2022 | II | cGMP deviations | Ultra Seal Corporation |
| 15 mars 2021 | II | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. |
| 24 juin 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 juin 2019 | II | Lack of Assurance of Sterility | Infusion Options, Inc. |
| 31 mai 2019 | II | cGMP Deviations: Products may have microbial contamination. | Geritrex, LLC |
| 21 mai 2019 | II | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). | Torrent Pharma Inc |
| 21 mai 2019 | II | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). | Torrent Pharma Inc |
| 9 févr. 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 août 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 août 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 janv. 2017 | III | Subpotent | InnovaGel |
| 28 mai 2015 | II | Lack of Assurance of Sterility: Sterility of product is not assured. | Lincare, Inc. |
| 6 mars 2015 | II | Microbial Contamination of a Non-Sterile Product: Kit component is contaminated with Burkholderia multivorans. | Fusion Pharmaceuticals, LLC |
| 26 déc. 2014 | II | Lack of sterility assurance. | Walgreens Infusion Services |
| 25 avr. 2014 | III | Presence of Precipitate; small amounts of diphenhydramine precipitated out of solution | Prestige Brands Holdings |
| 15 avr. 2014 | III | Presence of Precipitate: Small amounts of diphenydramine and mannitol precipitated out of solution. | P&L Developments, LLC |
| 2 juil. 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 juin 2013 | II | Presence of Foreign Substance: The products are being recalled because they may contain foreign substances. | Novartis Consumer Health |
| 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 |
| 25 mai 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 |
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 Best Choice 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.