Manufacturer profile
Advanced Rx of Tennessee, LLC
Pharmaceutical company5 products tracked
5
products tracked
604,577
total reports
85
recalls on record
51.2%
serious overall
Products
showing 5 of 5
| Product | Approved | Reports ↓ | Top signal | Recalls |
|---|---|---|---|---|
| 1981 | 291,471 | Device delivery system issue | 42 | |
| 1995 | 289,568 | Device delivery system issue | 30 | |
| 1981 | 12,337 | Dermatitis atopic | 12 | |
| 2002 | 6,966 | Recalled product administered | 1 | |
| 2007 | 4,235 | Application site rash | 0 |
Recall history · 43 on record
| Date | Class | Reason | Firm |
|---|---|---|---|
| Mar 17, 2026 | II | Labelling: Illegible label | Nephron SC, LLC |
| Jul 24, 2025 | III | Failed Stability Specifications: Out of specification results was observed in Induction Port during the analysis of Particle size distribution at the 12-month time point. | Cipla USA, Inc. |
| May 14, 2025 | II | Defective delivery system | AsttraZeneca Pharmaceuticals LP |
| Mar 26, 2024 | II | Short fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch. | Cipla USA, Inc. |
| Jun 27, 2023 | I | Defective container: empty inhaler and leakage observed through the inhaler valve due to partially missing bottom seat (gasket). | Cipla USA, Inc. |
| Apr 26, 2023 | II | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. |
| Dec 22, 2022 | II | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Pharmacy Innovations |
| Apr 13, 2022 | III | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | II | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | II | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | II | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | II | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | II | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | II | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | II | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office |
| Jan 26, 2022 | II | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | CARDINAL HEALTHCARE |
| Jan 26, 2022 | II | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | CARDINAL HEALTHCARE |
| Jan 26, 2022 | II | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | CARDINAL HEALTHCARE |
| Mar 15, 2021 | II | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. |
| Mar 15, 2021 | II | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. |
| Sep 16, 2020 | II | Defective Delivery System: Sustained trend of failure to dispense complaints. | Perrigo Company PLC |
| Nov 12, 2019 | II | Lack of Processing Controls | Integrated Health Concepts Inc. dba Conversio Health |
| Nov 12, 2019 | II | Lack of Processing Controls | Integrated Health Concepts Inc. dba Conversio Health |
| Nov 12, 2019 | II | Lack of Processing Controls | Integrated Health Concepts Inc. dba Conversio Health |
| Nov 12, 2019 | II | Lack of Processing Controls | Integrated Health Concepts Inc. dba Conversio Health |
| Nov 12, 2019 | II | Lack of Processing Controls | Integrated Health Concepts Inc. dba Conversio Health |
| Nov 12, 2019 | II | Lack of Processing Controls | Integrated Health Concepts Inc. dba Conversio Health |
| Nov 12, 2019 | II | Lack of Processing Controls | Integrated Health Concepts Inc. dba Conversio Health |
| Nov 12, 2019 | II | Lack of Processing Controls | Integrated Health Concepts Inc. dba Conversio Health |
| Apr 3, 2018 | II | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. |
| Jul 25, 2017 | III | Failed Impurities/Degradation Specifications: high out of specification results for related compound D. | Teva Pharmaceuticals USA |
| May 16, 2017 | II | Defective Delivery System: Elevated number of units with out of specification results for leak rate | GlaxoSmithKline, LLC |
| Mar 22, 2017 | II | Defective Delivery System: Elevated number of units with out of specification results for leak rate. | GlaxoSmithKline, LLC |
| Jan 12, 2017 | III | Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant. | Actavis Inc |
| Jun 22, 2016 | II | Presence of Foreign Substance; presence of black particles describes generically as cellulose-based bundles of brown fibrous material. | Teva North America |
| Dec 3, 2015 | II | Defective Delivery System: Some canisters may not contain sufficient propellant to deliver the labeled claim of 200 actuations through the end of shelf life. | GlaxoSmithKline, LLC |
| Aug 21, 2015 | II | Lack of Assurance of Sterility; potential exposure to non-sterile lubricant during the filling process | Nephron Pharmaceuticals Corp. |
| Jul 24, 2015 | II | Defective Delivery System: Inhalers do not spray properly, emitting either no spray or a short transient spray. | Boehringer Ingelheim Roxane Inc |
| Nov 14, 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 |
| Oct 2, 2013 | II | Lack of Assurance of Sterility: Nephron Pharmaceuticals Corporation conducted a routine periodic aseptic process simulation and discovered bacterial growth in a number of media fill vials, exceeding the allowable limit. | Nephron Pharmaceuticals Corp. |
| Jul 2, 2013 | II | Labeling: Label Mixup: ALBUTEROL SULFATE ER, Tablet, 4 mg may have potentially been mislabeled as one of the following drugs: SIMVASTATIN, Tablet, 20 mg, NDC 16714068303, Pedigree: W003580, EXP: 6/24/2014. | Aidapak Services, LLC |
| Jul 26, 2012 | II | Does Not Deliver Proper Metered Dose: Potential content of albuterol per dose is below specification. | GlaxoSmithKline Inc |
| Jun 22, 2011 | II | Lack of Assurance of Sterility | Nephron Pharmaceuticals Corp. |
Class I = reasonable probability of serious harm · Class II = temporary or reversible · Class III = unlikely to cause harm.
Registration status
Some products from Advanced Rx of Tennessee, LLC are not FDA-registered for human use. For unregistered substances (peptides, SARMs without human registration), no legitimate human-use supplier exists. The absence of a sourcing route is the safety information.