Fabrikant-profiel
Aphena Pharma Solutions - Tennessee, LLC
Farmaceutisch bedrijf14 producten gevolgd
14
producten gevolgd
218.089
totaal meldingen
81
recalls geregistreerd
62,9%
ernstig algeheel
Producten
14 van 14 getoond
| Product | Goedgekeurd | Meldingen ↓ | Top signaal | Recalls |
|---|---|---|---|---|
| 1981 | 46.183 | Premature bevalling | 21 | |
| 1979 | 37.162 | Roodheid op de toedieningsplaats | 10 | |
| 1999 | 25.682 | Rectale afscheiding | 0 | |
| 1957 | 19.125 | chronische nierziekte | 16 | |
| — | 15.501 | chronische nierziekte | 3 | |
| — | 15.493 | chronische nierziekte | 0 | |
| — | 13.473 | colitis | 1 | |
| 1998 | 10.888 | Longtoxiciteit | 4 | |
| 1987 | 8.752 | ernstige nierziekte | 0 | |
| 1987 | 8.752 | ernstige nierziekte | 0 | |
| 1979 | 8.547 | Multiple sclerose | 10 | |
| 1999 | 6.069 | Cerebraal infarct | 5 | |
| — | 2.169 | duizeligheid | 0 | |
| — | 293 | verkeersongeval | 11 |
Recall-geschiedenis · 50 geregistreerd
| Datum | Klasse | Reden | Bedrijf |
|---|---|---|---|
| 16 mrt 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 sep 2023 | II | Failed Dissolution Specifications | Zydus Pharmaceuticals (USA) Inc |
| 27 jun 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 mrt 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 sep 2021 | II | Labeling: Incorrect Instructions | RISING PHARMACEUTICALS |
| 2 jul 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 mrt 2019 | III | Failed Dissolution Specifications | AVKARE Inc. |
| 21 feb 2019 | III | Failed Dissolution Specifications | Lannett Company Inc. |
| 11 dec 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 mrt 2017 | III | Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib | Alvogen, Inc |
| 7 mrt 2017 | III | Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib | Alvogen, Inc |
| 7 mrt 2017 | III | Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib | Alvogen, Inc |
| 7 mrt 2017 | III | Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib | Alvogen, Inc |
| 7 mrt 2017 | III | Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib | Alvogen, Inc |
| 7 mrt 2017 | III | Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib | Alvogen, Inc |
| 7 mrt 2017 | III | Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib | Alvogen, Inc |
| 7 mrt 2017 | III | Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib | Alvogen, Inc |
| 7 mrt 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 mrt 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 jul 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 jul 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 jul 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 jul 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 jul 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 |
Class I = redelijke kans op ernstige schade · Class II = tijdelijk of omkeerbaar · Class III = onwaarschijnlijk schadelijk.
Registratiestatus
Sommige producten van Aphena Pharma Solutions - Tennessee, LLC 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.