Herstellerprofil
Advagen Pharma Ltd.
Pharmaunternehmen3 erfasste Produkte
3
erfasste Produkte
255.687
Meldungen insgesamt
128
dokumentierte Rückrufe
56,5%
schwerwiegend insgesamt
Produkte
3 von 3 angezeigt
| Produkt | Zugelassen | Meldungen ↓ | Top-Signal | Rückrufe |
|---|---|---|---|---|
| 1990 | 189.078 | Asthma | 19 | |
| — | 37.381 | Asthma | 100 | |
| — | 29.228 | Asthma | 9 |
Rückrufhistorie · 50 dokumentiert
| Datum | Klasse | Grund | Firma |
|---|---|---|---|
| 8. Apr. 2026 | II | Defective container: defect in a batch of bottle caps, specifically involving dislodged or missing cap liners. | Apotex Corp. |
| 12. Dez. 2025 | I | Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter. | Medinatura New Mexico, inc. |
| 12. Dez. 2025 | I | Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter. | Medinatura New Mexico, inc. |
| 14. Feb. 2024 | II | CGMP Deviations:Suspected potential presence of Burkholderia cepacia complex | Golden State Medical Supply Inc. |
| 9. Feb. 2024 | II | CGMP Deviations: potential presence of Burkholderia cepacia complex | Apotex Corp. |
| 28. Dez. 2023 | II | CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products. | Seaway Pharma Inc. |
| 28. Dez. 2023 | II | CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products. | Seaway Pharma Inc. |
| 26. Apr. 2023 | II | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. |
| 23. Feb. 2023 | II | CGMP Deviations: Raw material recalled by repackager, due to discoloration. | Nutraceutical Corporation |
| 23. Feb. 2023 | II | CGMP Deviations: Raw material recalled by repackager, due to discoloration. | Nutraceutical Corporation |
| 13. Juni 2022 | II | Defective container: defect prevents product from dispensing as intended. | Akorn, Inc. |
| 26. Jan. 2022 | II | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | CARDINAL HEALTHCARE |
| 26. Jan. 2022 | II | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | CARDINAL HEALTHCARE |
| 26. Jan. 2022 | II | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | CARDINAL HEALTHCARE |
| 24. Jan. 2022 | II | cGMP deviations | Ultra Seal Corporation |
| 26. Okt. 2021 | II | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. | Perrigo Company PLC |
| 26. Okt. 2021 | II | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. | Perrigo Company PLC |
| 26. Okt. 2021 | II | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. | Perrigo Company PLC |
| 26. Okt. 2021 | II | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. | Perrigo Company PLC |
| 26. Okt. 2021 | II | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. | Perrigo Company PLC |
| 26. Okt. 2021 | II | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. | Perrigo Company PLC |
| 26. Okt. 2021 | II | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. | Perrigo Company PLC |
| 22. Sept. 2021 | II | Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol | Teva Pharmaceuticals USA |
| 22. Sept. 2021 | II | Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol | Teva Pharmaceuticals USA |
| 22. Sept. 2021 | II | Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol | Teva Pharmaceuticals USA |
| 22. Sept. 2021 | II | Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol | Teva Pharmaceuticals USA |
| 22. Sept. 2021 | II | Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol | Teva Pharmaceuticals USA |
| 15. März 2021 | II | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. |
| 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 |
| 3. Aug. 2018 | II | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC |
| 3. Aug. 2018 | II | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC |
| 3. Aug. 2018 | II | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC |
| 3. Aug. 2018 | II | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC |
| 3. Aug. 2018 | II | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Product Quest Manufacturing LLC |
| 3. Aug. 2018 | I | Microbial Contamination of Non-Sterile Products: Failed microbiological testing for Pseudomonas aeruginosa. | Product Quest Manufacturing LLC |
| 31. Mai 2018 | II | Presence of foreign substance: glass particles | Apotex 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 |
| 5. Juli 2016 | II | Marketed Without An Approved NDA/ANDA: product is an unapproved drug due to nasal decongestant claims as well as not complying with the nasal decongestant final monograph. | Let's Talk Health, Inc. |
| 27. Feb. 2015 | II | Failed Stability Specifications: Out of specification for preservative, benazalkonium chloride. | 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 |
| 30. Jan. 2013 | II | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | TG United, Inc. |
| 30. Jan. 2013 | II | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | TG United, Inc. |
| 30. Jan. 2013 | II | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | TG United, Inc. |
| 30. Jan. 2013 | II | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | TG United, Inc. |
| 30. Jan. 2013 | II | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | TG United, Inc. |
| 30. Jan. 2013 | II | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | TG United, Inc. |
| 30. Jan. 2013 | II | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | TG United, Inc. |
| 30. Jan. 2013 | II | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | TG United, Inc. |
| 18. Dez. 2012 | I | Microbial Contamination of Non-Sterile Products: Product may be contaminated with Burkholderia cepacia. | Matrixx Initiatives Inc |
Klasse I = begründete Wahrscheinlichkeit schwerwiegender Schäden · Klasse II = vorübergehend oder reversibel · Klasse III = Schaden unwahrscheinlich.
Registrierungsstatus
Einige Produkte von Advagen Pharma Ltd. 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.