Fabrikant-profiel
Best Choice
Farmaceutisch bedrijf2 producten gevolgd
2
producten gevolgd
214.547
totaal meldingen
81
recalls geregistreerd
67,4%
ernstig algeheel
Producten
2 van 2 getoond
| Product | Goedgekeurd | Meldingen ↓ | Top signaal | Recalls |
|---|---|---|---|---|
| 1972 | 195.250 | infuusgerelateerde reactie | 49 | |
| — | 19.297 | infuusgerelateerde reactie | 32 |
Recall-geschiedenis · 29 geregistreerd
| Datum | Klasse | Reden | Bedrijf |
|---|---|---|---|
| 26 mrt 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 mrt 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 dec 2024 | III | Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID. | Akron Pharma, Inc. |
| 12 dec 2024 | III | Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID. | Akron Pharma, Inc. |
| 12 dec 2024 | III | Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID. | Akron Pharma, Inc. |
| 28 apr 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 dec 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 apr 2022 | II | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office |
| 24 jan 2022 | II | cGMP deviations | Ultra Seal Corporation |
| 15 mrt 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 mei 2019 | II | cGMP Deviations: Products may have microbial contamination. | Geritrex, LLC |
| 21 mei 2019 | II | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). | Torrent Pharma Inc |
| 21 mei 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 aug 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 aug 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 jan 2017 | III | Subpotent | InnovaGel |
| 28 mei 2015 | II | Lack of Assurance of Sterility: Sterility of product is not assured. | Lincare, Inc. |
| 6 mrt 2015 | II | Microbial Contamination of a Non-Sterile Product: Kit component is contaminated with Burkholderia multivorans. | Fusion Pharmaceuticals, LLC |
| 26 dec 2014 | II | Lack of sterility assurance. | Walgreens Infusion Services |
| 25 apr 2014 | III | Presence of Precipitate; small amounts of diphenhydramine precipitated out of solution | Prestige Brands Holdings |
| 15 apr 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 mei 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 mei 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 |
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Registratiestatus
Sommige producten van Best Choice zijn niet FDA-geregistreerd voor humaan gebruik. Voor ongeregistreerde stoffen (peptiden, SARMs zonder humane registratie) bestaat geen legitieme leverancier voor humaan gebruik. Het ontbreken van een inkooproute is de veiligheidsinformatie.