Profil du fabricant
Aphena Pharma Solutions - Tennessee, LLC
Société pharmaceutique14 produits suivis
14
produits suivis
218 089
total des notifications
81
rappels enregistrés
62,9%
graves au total
Produits
affichage de 14 sur 14
| Produit | Approuvé | Notifications ↓ | Signal principal | Rappels |
|---|---|---|---|---|
| 1981 | 46 183 | Accouchement prématuré | 21 | |
| 1979 | 37 162 | Rougeur au site d'application | 10 | |
| 1999 | 25 682 | Écoulement rectal | 0 | |
| 1957 | 19 125 | Maladie rénale chronique | 16 | |
| — | 15 501 | Maladie rénale chronique | 3 | |
| — | 15 493 | Maladie rénale chronique | 0 | |
| — | 13 473 | colite | 1 | |
| 1998 | 10 888 | toxicité pulmonaire | 4 | |
| 1987 | 8 752 | Insuffisance rénale terminale | 0 | |
| 1987 | 8 752 | Insuffisance rénale terminale | 0 | |
| 1979 | 8 547 | Sclérose en plaques | 10 | |
| 1999 | 6 069 | infarctus cérébral | 5 | |
| — | 2 169 | vertige | 0 | |
| — | 293 | Accident de la voie publique | 11 |
Historique des rappels · 50 enregistrés
| Date | Classe | Motif | Fabricant |
|---|---|---|---|
| 16 mars 2026 | II | Failed tablet specifications. | Amerisource Health Services LLC |
| 19 oct. 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 oct. 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 oct. 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 juin 2022 | I | Subpotent and Superpotent Drug | Valor Compounding Pharmacy, Inc DBA Valor Compounding Pharmacy |
| 13 avr. 2022 | II | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office |
| 8 mars 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 juil. 2021 | II | Failed Dissolution Specification: Out of specification for dissolution during routine stability testing. | The Harvard Drug Group |
| 4 févr. 2021 | II | Failed Dissolution Specifications | Wilshire Pharmaceuticals Inc |
| 4 févr. 2021 | II | Failed Dissolution Specifications | Wilshire Pharmaceuticals Inc |
| 17 août 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 oct. 2019 | III | Subpotent Drug | Sato Pharmaceutical Inc. |
| 1 oct. 2019 | III | Subpotent Drug | Sato Pharmaceutical Inc. |
| 1 oct. 2019 | III | Subpotent Drug | Sato Pharmaceutical Inc. |
| 1 oct. 2019 | III | Subpotent Drug | Sato Pharmaceutical Inc. |
| 1 mars 2019 | III | Failed Dissolution Specifications | AVKARE Inc. |
| 21 févr. 2019 | III | Failed Dissolution Specifications | Lannett Company Inc. |
| 11 déc. 2018 | II | Labeling: Wrong bar code | KVK-Tech, Inc. |
| 30 oct. 2017 | III | Marketed without an approved NDA/ANDA: Bottles were released prior to final approval. | Jubilant Cadista Pharmaceuticals, Inc. |
| 7 mars 2017 | III | Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib | Alvogen, Inc |
| 7 mars 2017 | III | Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib | Alvogen, Inc |
| 7 mars 2017 | III | Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib | Alvogen, Inc |
| 7 mars 2017 | III | Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib | Alvogen, Inc |
| 7 mars 2017 | III | Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib | Alvogen, Inc |
| 7 mars 2017 | III | Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib | Alvogen, Inc |
| 7 mars 2017 | III | Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib | Alvogen, Inc |
| 7 mars 2017 | III | Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib | Alvogen, Inc |
| 7 mars 2017 | III | Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib | Alvogen, Inc |
| 13 oct. 2016 | III | Presence of Foreign Tablets/Capsules | Amerisource Health Services |
| 6 oct. 2016 | III | Presence of Foreign Tablets/Capsules | Actavis Elizabeth LLC |
| 25 mars 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 oct. 2015 | III | Failed Impurities/Degradation Specifications: Out of specification for impurities. | Par Pharmaceutical Inc. |
| 26 oct. 2015 | III | Failed Impurities/Degradation Specifications: Out of specification for impurities. | Par Pharmaceutical Inc. |
| 17 avr. 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 févr. 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 juil. 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 juil. 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 juil. 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 juil. 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 juil. 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 |
Classe I = probabilité raisonnable de préjudice grave · Classe II = temporaire ou réversible · Classe III = peu susceptible de causer un préjudice.
Statut d'enregistrement
Certains produits de Aphena Pharma Solutions - Tennessee, LLC ne sont pas enregistrés auprès de la FDA pour un usage humain. Pour les substances non enregistrées (peptides, SARMs sans enregistrement humain), aucun fournisseur légitime à usage humain n'existe. L'absence de filière d'approvisionnement est l'information de sécurité.