Herstellerprofil
Best Choice
Pharmaunternehmen2 erfasste Produkte
2
erfasste Produkte
214.547
Meldungen insgesamt
81
dokumentierte Rückrufe
67,4%
schwerwiegend insgesamt
Produkte
2 von 2 angezeigt
| Produkt | Zugelassen | Meldungen ↓ | Top-Signal | Rückrufe |
|---|---|---|---|---|
| 1972 | 195.250 | Infusionsbedingte Reaktion | 49 | |
| — | 19.297 | Infusionsbedingte Reaktion | 32 |
Rückrufhistorie · 29 dokumentiert
| Datum | Klasse | Grund | Firma |
|---|---|---|---|
| 26. März 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. März 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. Dez. 2024 | III | Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID. | Akron Pharma, Inc. |
| 12. Dez. 2024 | III | Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID. | Akron Pharma, Inc. |
| 12. Dez. 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. Dez. 2022 | II | Lack of sterility assurance | Sentara Infusion Services |
| 23. Juni 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. März 2021 | II | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. |
| 24. Juni 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. Juni 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. 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. Mai 2015 | II | Lack of Assurance of Sterility: Sterility of product is not assured. | Lincare, Inc. |
| 6. März 2015 | II | Microbial Contamination of a Non-Sterile Product: Kit component is contaminated with Burkholderia multivorans. | Fusion Pharmaceuticals, LLC |
| 26. Dez. 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. Juli 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. Juni 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 |
Klasse I = begründete Wahrscheinlichkeit schwerwiegender Schäden · Klasse II = vorübergehend oder reversibel · Klasse III = Schaden unwahrscheinlich.
Registrierungsstatus
Einige Produkte von Best Choice sind nicht für die Anwendung am Menschen FDA-registriert. Für nicht registrierte Substanzen (Peptide, SARMs ohne Humanzulassung) existiert kein legitimer Anbieter für die Anwendung am Menschen. Das Fehlen eines Bezugswegs ist die Sicherheitsinformation.