Herstellerprofil
Aphena Pharma Solutions - Tennessee, LLC
Pharmaunternehmen14 erfasste Produkte
14
erfasste Produkte
218.089
Meldungen insgesamt
81
dokumentierte Rückrufe
62,9%
schwerwiegend insgesamt
Produkte
14 von 14 angezeigt
| Produkt | Zugelassen | Meldungen ↓ | Top-Signal | Rückrufe |
|---|---|---|---|---|
| 1981 | 46.183 | Vorzeitige Geburt | 21 | |
| 1979 | 37.162 | Rötung an der Anwendungsstelle | 10 | |
| 1999 | 25.682 | Ausfluss aus dem Darm | 0 | |
| 1957 | 19.125 | Chronische Nierenerkrankung | 16 | |
| — | 15.501 | Chronische Nierenerkrankung | 3 | |
| — | 15.493 | Chronische Nierenerkrankung | 0 | |
| — | 13.473 | Darmentzündung | 1 | |
| 1998 | 10.888 | Lungentoxizität | 4 | |
| 1987 | 8.752 | Nierenversagen im Endstadium | 0 | |
| 1987 | 8.752 | Nierenversagen im Endstadium | 0 | |
| 1979 | 8.547 | Multiple Sklerose | 10 | |
| 1999 | 6.069 | Hirninfarkt | 5 | |
| — | 2.169 | Schwindel | 0 | |
| — | 293 | Verkehrsunfall | 11 |
Rückrufhistorie · 50 dokumentiert
| Datum | Klasse | Grund | Firma |
|---|---|---|---|
| 16. März 2026 | II | Failed tablet specifications. | Amerisource Health Services LLC |
| 19. Okt. 2023 | II | Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point. | Zydus Pharmaceuticals (USA) Inc |
| 19. Okt. 2023 | II | Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point. | Zydus Pharmaceuticals (USA) Inc |
| 19. Okt. 2023 | II | Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point. | Zydus Pharmaceuticals (USA) Inc |
| 21. Sept. 2023 | II | Failed Dissolution Specifications | Zydus Pharmaceuticals (USA) Inc |
| 27. Juni 2022 | I | Subpotent and Superpotent Drug | Valor Compounding Pharmacy, Inc DBA Valor Compounding Pharmacy |
| 13. Apr. 2022 | II | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office |
| 8. März 2022 | I | Labeling: Label mix-up: Incorrect label placed on product. Shipper cases labeled Meclizine Hydrochloride Tablets contain bottles incorrectly labeled as PredniSONE Tablets. The tablets in the bottles are Meclizine Hydrochloride | Jubilant Cadista Pharmaceuticals, Inc. |
| 2. Sept. 2021 | II | Labeling: Incorrect Instructions | RISING PHARMACEUTICALS |
| 2. Juli 2021 | II | Failed Dissolution Specification: Out of specification for dissolution during routine stability testing. | The Harvard Drug Group |
| 4. Feb. 2021 | II | Failed Dissolution Specifications | Wilshire Pharmaceuticals Inc |
| 4. Feb. 2021 | II | Failed Dissolution Specifications | Wilshire Pharmaceuticals Inc |
| 17. Aug. 2020 | I | Labeling: Label Mix-Up; potential for cartons labeled as Tranexamic Acid Injection, USP to contain vials of Amiodarone HCl Injection, USP and cartons labeled as Amiodarone HCl Injection, USP to contain vials of Tranexamic Acid Injection, USP. | Mylan Institutional LLC |
| 11. Nov. 2019 | III | Crystallization: Presence of visible particulate matter. | AuroMedics Pharma LLC |
| 11. Nov. 2019 | III | Crystallization: Presence of visible particulate matter. | AuroMedics Pharma LLC |
| 11. Nov. 2019 | III | Crystallization: Presence of visible particulate matter. | AuroMedics Pharma LLC |
| 1. Okt. 2019 | III | Subpotent Drug | Sato Pharmaceutical Inc. |
| 1. Okt. 2019 | III | Subpotent Drug | Sato Pharmaceutical Inc. |
| 1. Okt. 2019 | III | Subpotent Drug | Sato Pharmaceutical Inc. |
| 1. Okt. 2019 | III | Subpotent Drug | Sato Pharmaceutical Inc. |
| 1. März 2019 | III | Failed Dissolution Specifications | AVKARE Inc. |
| 21. Feb. 2019 | III | Failed Dissolution Specifications | Lannett Company Inc. |
| 11. Dez. 2018 | II | Labeling: Wrong bar code | KVK-Tech, Inc. |
| 30. Okt. 2017 | III | Marketed without an approved NDA/ANDA: Bottles were released prior to final approval. | Jubilant Cadista Pharmaceuticals, Inc. |
| 7. März 2017 | III | Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib | Alvogen, Inc |
| 7. März 2017 | III | Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib | Alvogen, Inc |
| 7. März 2017 | III | Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib | Alvogen, Inc |
| 7. März 2017 | III | Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib | Alvogen, Inc |
| 7. März 2017 | III | Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib | Alvogen, Inc |
| 7. März 2017 | III | Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib | Alvogen, Inc |
| 7. März 2017 | III | Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib | Alvogen, Inc |
| 7. März 2017 | III | Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib | Alvogen, Inc |
| 7. März 2017 | III | Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib | Alvogen, Inc |
| 13. Okt. 2016 | III | Presence of Foreign Tablets/Capsules | Amerisource Health Services |
| 6. Okt. 2016 | III | Presence of Foreign Tablets/Capsules | Actavis Elizabeth LLC |
| 25. März 2016 | II | Lack of Processing Controls | Reliable Rexall-A Compounding Pharmacy |
| 25. Nov. 2015 | III | Failed Impurities/Degradation Specifications: Out of specification for impurities. | Golden State Medical Supply Inc. |
| 25. Nov. 2015 | III | Failed Impurities/Degradation Specifications: Out of specification for impurities. | Golden State Medical Supply Inc. |
| 2. Nov. 2015 | III | Failed Impurities/Degradation Specifications: Out of specification for impurities. | Mylan Institutional, Inc. (d.b.a. UDL Laboratories) |
| 26. Okt. 2015 | III | Failed Impurities/Degradation Specifications: Out of specification for impurities. | Par Pharmaceutical Inc. |
| 26. Okt. 2015 | III | Failed Impurities/Degradation Specifications: Out of specification for impurities. | Par Pharmaceutical Inc. |
| 17. Apr. 2015 | II | Failed Dissolution Specifications: High out of specification dissolution result at 1 hour time point. | Valeant Pharmaceuticals North America LLC |
| 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 |
| 7. Feb. 2014 | III | Subpotent Drug: Drug potency was compromised during shipment. | Actavis |
| 1. Nov. 2013 | II | Labeling: Incorrect or Missing Lot and/or Exp Date: Greenstone LLC is recalling Nifedipine Extended Release tablets (90mg). The expiration date on the package is 48 months instead of 36 months. | Greenstone Llc |
| 2. Juli 2013 | II | Labeling:Label Mixup; NIFEdipine, Capsule, 10 mg may be potentially mislabeled as NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALS, Capsule, 100 mg, NDC 47781030301, Pedigree: AD52778_58, EXP: 5/20/2014. | Aidapak Services, LLC |
| 2. Juli 2013 | II | Labeling: Label Mixup: OXYBUTYNIN CHLORIDE, Tablet, 5 mg may have potentially been mislabeled as one of the following drugs: FLECAINIDE ACETATE, Tablet, 100 mg, NDC 00054001125, Pedigree: AD56847_4, EXP: 5/21/2014; SODIUM CHLORIDE, Tablet, 1 gm, NDC 00223176001, Pedigree: W003792, EXP: 6/27/2014; VARENICLINE, Tablet, 0.5 mg, NDC 00069046856, Pedigree: AD22616_1, EXP: 5/2/2014. | Aidapak Services, LLC |
| 2. Juli 2013 | II | Labeling:Label Mixup; CILOSTAZOL Tablet, 100 mg may be potentially mislabeled as DUTASTERIDE, Capsule, 0.5 mg, NDC 00173071204, Pedigree: AD65475_1, EXP: 5/28/2014. | Aidapak Services, LLC |
| 2. Juli 2013 | II | Labeling: Label Mixup: OXYBUTYNIN CHLORIDE, Tablet, 2.5 mg (1/2 of 5 mg) may have potentially been mislabeled as the following drug: PIMOZIDE, Tablet, 1 mg (1/2 of 2 mg), NDC 57844018701, Pedigree: AD73525_61, EXP: 5/30/2014. | Aidapak Services, LLC |
| 2. Juli 2013 | II | Labeling: Label Mixup: CILOSTAZOL, Tablet, 100 mg may be potentially mislabeled as the following drug: CALCIUM ACETATE, Capsule, 667 mg, NDC 00054008826, Pedigree: W003469, EXP: 6/20/2014. | Aidapak Services, LLC |
Klasse I = begründete Wahrscheinlichkeit schwerwiegender Schäden · Klasse II = vorübergehend oder reversibel · Klasse III = Schaden unwahrscheinlich.
Registrierungsstatus
Einige Produkte von Aphena Pharma Solutions - Tennessee, LLC 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.