DrugNov 2, 2022
Fondaparinux Sodium Injection, USP, 7.5 mg per 0.6 mL, Single Dose, Prefilled Syringe recall — FDA D-0020-2023
Subpotent Drug: Out of specification for assay
Class IIFDA: TerminatedAuroMedics Pharma LLC
Recall history in this database
Classification mix: Class II: 14, Class I: 9, Class III: 7.
DrugOct 26, 2022
Acyclovir Sodium Injection, 500mg/10mL (50mg/mL), 10 mL Single Dose Vial recall — FDA D-0013-2023
Presence of Particulate Matter: Customer complaint for a dark red, brown and black particulate floating inside vial.
Class IIFDA: CompletedAuroMedics Pharma LLC
DrugOct 12, 2022
Tranexamic Acid Injection, USP, 1000mg per 10 mL (100mg /mL), 10mL single-dose vial recall — FDA D-1551-2022
Presence of Particulate Matter: Piece of metal found in a vial
Class IIIFDA: OngoingAuroMedics Pharma LLC
DrugFeb 16, 2022
Polymyxin B for Injection USP, 500,000 Units per Vial, 10 mL vials recall — FDA D-0556-2022
Presence of Particulate Matter; product complaint of hair discovered in a vial within the lot
Class IFDA: TerminatedAuroMedics Pharma LLC
DrugFeb 26, 2020
Glycopyrrolate Injection, USP 4 mg per 20 mL (0.2 mg/mL), 20 mL Multiple Dose Vial recall — FDA D-0853-2020
Failed Impurities/Degradation Specifications: elevated levels of Benzaldehyde impurity was found in investigative samples (retain samples).
Class IIIFDA: TerminatedAuroMedics Pharma LLC
DrugFeb 19, 2020
Amoxicillin and Clavulanate Potassium Tablets, USP, 875 mg/125 mg, 20-count bottles recall — FDA D-0852-2020
Presence of Foreign Substance: Customer complaint of a foreign substance identified as nylon cable tie
Class IIFDA: TerminatedAuroMedics Pharma LLC
DrugJan 22, 2020
Moxifloxacin Ophthalmic Solution USP, 0.5%, Sterile, 3mL Bottle recall — FDA D-0789-2020
Discoloration: Market complaints of discoloration in Moxifloxacin Ophthalmic Solution.
Class IIIFDA: TerminatedAuroMedics Pharma LLC
DrugDec 18, 2019
Vancomycin Hydrochloride for Injection, USP, 1 g* per vial recall — FDA D-0574-2020
Discoloration: Product complaints of discoloration after reconstitution of vials.
Class IIFDA: TerminatedAuroMedics Pharma LLC
DrugDec 18, 2019
Mirtazapine Tablets, USP, 15 mg, 500-count tablets recall — FDA D-0636-2020
Labeling: Label Error on Declared Strength; cases labelled Mirtazapine 15mg tablets, 500-count bottles, contain 500-count bottles of Mirtazapine 15mg tablets labelled as Mirtazapine 7.5 mg…
Class IFDA: TerminatedAuroMedics Pharma LLC
DrugDec 18, 2019
Mirtazapine Tablets, USP, 7.5 mg, 500-count tablets recall — FDA D-0637-2020
Labeling: Label Error on Declared Strength; cases labelled Mirtazapine 15mg tablets, 500-count bottles, contain 500-count bottles of Mirtazapine 15mg tablets labelled as Mirtazapine 7.5 mg…
Class IFDA: TerminatedAuroMedics Pharma LLC
DrugDec 11, 2019
AuroMedics Pharma Fluphenazine Decanoate Injection USP 125mg/5mL, (5 mL Multiple Dose Vial) recall — FDA D-0609-2020
Discoloration; Hazy solution found in one vial instead of a clear solution.
Class IIFDA: TerminatedAuroMedics Pharma LLC
DrugDec 4, 2019
AuroMedics Pharma Ranitidine Syrup recall — FDA D-0529-2020
CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
Class IIFDA: OngoingAuroMedics Pharma LLC
DrugDec 4, 2019
Amiodarone Hydrochloride Injection, USP, 150 mg per 3 mL (50 mg / mL), 3 mL Single Dose Vial recall — FDA D-0520-2020
Crystallization: Presence of visible particulate matter.
Class IIIFDA: TerminatedAuroMedics Pharma LLC
DrugDec 4, 2019
Amiodarone Hydrochloride Injection, USP, 450 mg per 9 mL (50 mg / mL), 9 mL Single Dose Vial recall — FDA D-0521-2020
Crystallization: Presence of visible particulate matter.
Class IIIFDA: TerminatedAuroMedics Pharma LLC
DrugDec 4, 2019
MARLIDO KIT Lidocaine HCl Injection, USP, 2% 100 mg/5 mL (20 mg/mL), Preservative-Free recall — FDA D-0573-2020
Presence of Foreign Substance: Foreign material found inside the vial.
Class IIFDA: TerminatedAuroMedics Pharma LLC
DrugDec 4, 2019
Amiodarone Hydrochloride Injection, USP, 900 mg per 18 mL (50 mg / mL), 18 mL Multiple Dose recall — FDA D-0522-2020
Crystallization: Presence of visible particulate matter.
Class IIIFDA: TerminatedAuroMedics Pharma LLC
DrugNov 6, 2019
AuroMedics Pharma Ranitidine Tablets USP,150 mg, 8-count bottles recall — FDA D-0166-2020
CGMP DEVIATIONS: One lot of Ranitidine Tablets USP, 150 mg is being recalled because some bottles were empty.
Class IIIFDA: OngoingAuroMedics Pharma LLC
DrugJul 18, 2018
Piperacillin and Tazobactam for Injection USP 3.375 grams per vial, Single-Dose Vial recall — FDA D-1030-2018
Presence of Particulate Matter: identified as glass and silicone material
Class IFDA: TerminatedAuroMedics Pharma LLC
DrugMay 23, 2018
Piperacillin and Tazobactam for Injection, USP 3.375 grams per vial, For Intravenous Use recall — FDA D-0926-2018
Presence of Particulate Matter: confirmed customer report for presence of visible particulate matter, confirmed as glass
Class IFDA: TerminatedAuroMedics Pharma LLC
DrugMay 16, 2018
Ampicillin and Sulbactam for Injection, USP, 3 gram*s/vial, For Intramuscular or Intravenous recall — FDA D-0866-2018
Presence of Particulate Matter: confirmed customer report of the presence of visible particulate matter believed to be red rubber particles from the manufacturing process of the active…
Class IFDA: TerminatedAuroMedics Pharma LLC
DrugMay 9, 2018
Levofloxacin in 5% Dextrose Injection, 750 mg Levofloxacin (5 mg/mL) in 150 mL of 5% recall — FDA D-0709-2018
Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
Class IIFDA: TerminatedAuroMedics Pharma LLC
DrugMay 9, 2018
Levetiracetam in 0.54% Sodium Chloride Injection, 1,500 mg per 100 mL (15 mg/mL), For recall — FDA D-0707-2018
Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
Class IIFDA: TerminatedAuroMedics Pharma LLC
DrugMay 9, 2018
Levetiracetam in 0.82% Sodium Chloride Injection, 500 mg per 100 mL (5 mg/mL), For recall — FDA D-0705-2018
Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
Class IIFDA: TerminatedAuroMedics Pharma LLC
DrugMay 9, 2018
Levofloxacin in 5% Dextrose Injection, 250 mg Levofloxacin (5 mg/mL) in 50 mL of 5% recall — FDA D-0704-2018
Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
Class IIFDA: TerminatedAuroMedics Pharma LLC
Understanding this recall history
This page summarizes recall records in which the official source identifies AuroMedics Pharma LLC as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.