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Aphena Pharma Solutions - Tennessee, LLC

Pharmaceutical company14 products tracked
14
products tracked
218,089
total reports
81
recalls on record
62.9%
serious overall
Products
showing 14 of 14
ProductApprovedReports ↓Top signalRecalls
198146,183Premature delivery21
197937,162Application site erythema10
199925,682Rectal discharge0
195719,125Chronic kidney disease16
—15,501Chronic kidney disease3
—15,493Chronic kidney disease0
—13,473Colitis1
199810,888Pulmonary toxicity4
19878,752End stage renal disease0
19878,752End stage renal disease0
19798,547Multiple sclerosis10
19996,069Cerebral infarction5
—2,169Vertigo0
—293Road traffic accident11
Recall history · 50 on record
DateClassReasonFirm
Mar 16, 2026IIFailed tablet specifications.Amerisource Health Services LLC
Oct 19, 2023IIFailed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.Zydus Pharmaceuticals (USA) Inc
Oct 19, 2023IIFailed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.Zydus Pharmaceuticals (USA) Inc
Oct 19, 2023IIFailed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.Zydus Pharmaceuticals (USA) Inc
Sep 21, 2023IIFailed Dissolution SpecificationsZydus Pharmaceuticals (USA) Inc
Jun 27, 2022ISubpotent and Superpotent DrugValor Compounding Pharmacy, Inc DBA Valor Compounding Pharmacy
Apr 13, 2022IIcGMP deviations: Temperature abuseMckesson Medical-Surgical Inc. Corporate Office
Mar 8, 2022ILabeling: 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 HydrochlorideJubilant Cadista Pharmaceuticals, Inc.
Sep 2, 2021IILabeling: Incorrect InstructionsRISING PHARMACEUTICALS
Jul 2, 2021IIFailed Dissolution Specification: Out of specification for dissolution during routine stability testing.The Harvard Drug Group
Feb 4, 2021IIFailed Dissolution SpecificationsWilshire Pharmaceuticals Inc
Feb 4, 2021IIFailed Dissolution SpecificationsWilshire Pharmaceuticals Inc
Aug 17, 2020ILabeling: 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
Nov 11, 2019IIICrystallization: Presence of visible particulate matter.AuroMedics Pharma LLC
Nov 11, 2019IIICrystallization: Presence of visible particulate matter.AuroMedics Pharma LLC
Nov 11, 2019IIICrystallization: Presence of visible particulate matter.AuroMedics Pharma LLC
Oct 1, 2019IIISubpotent DrugSato Pharmaceutical Inc.
Oct 1, 2019IIISubpotent DrugSato Pharmaceutical Inc.
Oct 1, 2019IIISubpotent DrugSato Pharmaceutical Inc.
Oct 1, 2019IIISubpotent DrugSato Pharmaceutical Inc.
Mar 1, 2019IIIFailed Dissolution SpecificationsAVKARE Inc.
Feb 21, 2019IIIFailed Dissolution SpecificationsLannett Company Inc.
Dec 11, 2018IILabeling: Wrong bar codeKVK-Tech, Inc.
Oct 30, 2017IIIMarketed without an approved NDA/ANDA: Bottles were released prior to final approval.Jubilant Cadista Pharmaceuticals, Inc.
Mar 7, 2017IIICross Contamination with another product:residual powder found in inlet air duct identified as sorafenibAlvogen, Inc
Mar 7, 2017IIICross Contamination with another product:residual powder found in inlet air duct identified as sorafenibAlvogen, Inc
Mar 7, 2017IIICross Contamination with another product:residual powder found in inlet air duct identified as sorafenibAlvogen, Inc
Mar 7, 2017IIICross Contamination with another product:residual powder found in inlet air duct identified as sorafenibAlvogen, Inc
Mar 7, 2017IIICross Contamination with another product:residual powder found in inlet air duct identified as sorafenibAlvogen, Inc
Mar 7, 2017IIICross Contamination with another product:residual powder found in inlet air duct identified as sorafenibAlvogen, Inc
Mar 7, 2017IIICross Contamination with another product:residual powder found in inlet air duct identified as sorafenibAlvogen, Inc
Mar 7, 2017IIICross Contamination with another product:residual powder found in inlet air duct identified as sorafenibAlvogen, Inc
Mar 7, 2017IIICross Contamination with another product:residual powder found in inlet air duct identified as sorafenibAlvogen, Inc
Oct 13, 2016IIIPresence of Foreign Tablets/CapsulesAmerisource Health Services
Oct 6, 2016IIIPresence of Foreign Tablets/CapsulesActavis Elizabeth LLC
Mar 25, 2016IILack of Processing ControlsReliable Rexall-A Compounding Pharmacy
Nov 25, 2015IIIFailed Impurities/Degradation Specifications: Out of specification for impurities.Golden State Medical Supply Inc.
Nov 25, 2015IIIFailed Impurities/Degradation Specifications: Out of specification for impurities.Golden State Medical Supply Inc.
Nov 2, 2015IIIFailed Impurities/Degradation Specifications: Out of specification for impurities.Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Oct 26, 2015IIIFailed Impurities/Degradation Specifications: Out of specification for impurities.Par Pharmaceutical Inc.
Oct 26, 2015IIIFailed Impurities/Degradation Specifications: Out of specification for impurities.Par Pharmaceutical Inc.
Apr 17, 2015IIFailed Dissolution Specifications: High out of specification dissolution result at 1 hour time point.Valeant Pharmaceuticals North America LLC
Nov 14, 2014IIPenicillin 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
Feb 7, 2014IIISubpotent Drug: Drug potency was compromised during shipment.Actavis
Nov 1, 2013IILabeling: 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
Jul 2, 2013IILabeling: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
Jul 2, 2013IILabeling: 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
Jul 2, 2013IILabeling: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
Jul 2, 2013IILabeling: 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
Jul 2, 2013IILabeling: 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 = reasonable probability of serious harm · Class II = temporary or reversible · Class III = unlikely to cause harm.

Registration status

Some products from Aphena Pharma Solutions - 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.