Home / Brands / AuroMedics Pharma
AuroMedics Pharma Recalls
36 recalls on record · February 14, 2018 to November 2, 2022 · Drugs
Recalls by year
18
19
20
21
22
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
November 2, 2022DrugsFDA
AuroMedics Pharma LLC recalls Fondaparinux Sodium Injection, USP, 7.5 mg per 0.6 mL, Single Dose, Prefilled Syringe, Distributed by: AuroMedics Pharma
Hazard: Subpotent Drug: Out of specification for assay
October 26, 2022DrugsFDA
AuroMedics Pharma LLC recalls Acyclovir Sodium Injection, 500mg/10mL (50mg/mL), 10 mL Single Dose Vial, Rx only, Distributed by: AuroMedics Pharma LLC
Hazard: Presence of Particulate Matter: Customer complaint for a dark red, brown and black particulate floating inside vial.
October 12, 2022DrugsFDA
AuroMedics Pharma LLC recalls Tranexamic Acid Injection, USP, 1000mg per 10 mL (100mg /mL), 10mL single-dose vial, Rx Only, Distributed by: AuroMedics
Hazard: Presence of Particulate Matter: Piece of metal found in a vial
February 16, 2022DrugsFDA
AuroMedics Pharma LLC recalls Polymyxin B for Injection USP, 500,000 Units per Vial, 10 mL vials, packaged in 10 vials per carton, Sterile, Rx Only, D
Hazard: Presence of Particulate Matter; product complaint of hair discovered in a vial within the lot
February 10, 2021DrugsFDA
AuroMedics Pharma LLC recalls Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose Vial, For Intravenous Use Only, Distributed b
Hazard: Discoloration and failed pH specifications
February 26, 2020DrugsFDA
AuroMedics Pharma LLC recalls Glycopyrrolate Injection, USP 4 mg per 20 mL (0.2 mg/mL), 20 mL Multiple Dose Vial, Rx Only, For Intramuscular or Intrav
Hazard: Failed Impurities/Degradation Specifications: elevated levels of Benzaldehyde impurity was found in investigative samples (retain samples).
February 19, 2020DrugsFDA
AuroMedics Pharma LLC recalls Amoxicillin and Clavulanate Potassium Tablets, USP, 875 mg/125 mg, 20-count bottles, Distributed by: Aurobindo Pharma US
Hazard: Presence of Foreign Substance: Customer complaint of a foreign substance identified as nylon cable tie
January 22, 2020DrugsFDA
AuroMedics Pharma LLC recalls Moxifloxacin Ophthalmic Solution USP, 0.5%, Sterile, 3mL Bottle, Rx Only, For Topical Ophthalmic Use Only, Distributed b
Hazard: Discoloration: Market complaints of discoloration in Moxifloxacin Ophthalmic Solution.
December 25, 2019DrugsFDA
AuroMedics Pharma LLC recalls Gabapentin Capsules, USP 100 mg, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 65682-198-99
Hazard: Presence of Foreign Tablets/Capsules: One Losartan/HCTZ tablet was found in Gabapentin 1000 count bottles..
December 18, 2019DrugsFDA
AuroMedics Pharma LLC recalls Mirtazapine Tablets, USP, 7.5 mg, 500-count tablets, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 088
Hazard: 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 tablets.
December 18, 2019DrugsFDA
AuroMedics Pharma LLC recalls Mirtazapine Tablets, USP, 15 mg, 500-count tablets, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 0881
Hazard: 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 tablets.
December 18, 2019DrugsFDA
AuroMedics Pharma LLC recalls Vancomycin Hydrochloride for Injection, USP, 1 g* per vial, packaged in 10-count vials per carton, Rx only, Mft. in Indi
Hazard: Discoloration: Product complaints of discoloration after reconstitution of vials.
December 11, 2019DrugsFDA
AuroMedics Pharma LLC recalls Fluphenazine Decanoate Injection USP 125mg/5mL, (5 mL Multiple Dose Vial), Rx only, For IM or SC Use, Mfd in India for:
Hazard: Discoloration; Hazy solution found in one vial instead of a clear solution.
December 4, 2019DrugsFDA
AuroMedics Pharma LLC recalls Lidocaine HCl Injection, USP, 2% 100 mg/5 mL (20 mg/mL), Preservative-Free, packaged in 10 x 5 mL Single Dose Vials per
Hazard: Presence of Foreign Substance: Foreign material found inside the vial.
December 4, 2019DrugsFDA
AuroMedics Pharma LLC recalls Aurobindo Ranitidine Capsules 150 mg, 500 count bottle, Rx Only Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton
Hazard: CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
December 4, 2019DrugsFDA
AuroMedics Pharma LLC recalls Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg/5mL) 474 mL bottle, Rx only Distributed by: Aurobindo
Hazard: CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
December 4, 2019DrugsFDA
AuroMedics Pharma LLC recalls Aurobindo Ranitidine Capsules 300 mg, 30-count bottle, Rx Only Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-
Hazard: CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
December 4, 2019DrugsFDA
AuroMedics Pharma LLC recalls Aurobindo Ranitidine Caspules 150 mg, 60-count bottle, Rx Only Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-
Hazard: CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
December 4, 2019DrugsFDA
AuroMedics Pharma LLC recalls DG Health Acid Reducer Ranitidine Tablets 150 mg, 8-count carton, Distributed by: Dolgencorp LLC 100 Mission Ridge Goodl
Hazard: CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
December 4, 2019DrugsFDA
AuroMedics Pharma LLC recalls Amiodarone Hydrochloride Injection, USP, 900 mg per 18 mL (50 mg / mL), 18 mL Multiple Dose Vial, Rx only, Distributed b
Hazard: Crystallization: Presence of visible particulate matter.
December 4, 2019DrugsFDA
AuroMedics Pharma LLC recalls Amiodarone Hydrochloride Injection, USP, 450 mg per 9 mL (50 mg / mL), 9 mL Single Dose Vial, Rx only, Distributed by Au
Hazard: Crystallization: Presence of visible particulate matter.
December 4, 2019DrugsFDA
AuroMedics Pharma LLC recalls Amiodarone Hydrochloride Injection, USP, 150 mg per 3 mL (50 mg / mL), 3 mL Single Dose Vial, Rx only, Distributed by Au
Hazard: Crystallization: Presence of visible particulate matter.
November 6, 2019DrugsFDA
AuroMedics Pharma LLC recalls Ranitidine Tablets USP,150 mg, 8-count bottles, Distributed by: Dolgencorp, LLC, 100 Mission Ridge, Goodlettsville, TN
Hazard: CGMP DEVIATIONS: One lot of Ranitidine Tablets USP, 150 mg is being recalled because some bottles were empty.
July 18, 2018DrugsFDA
AuroMedics Pharma LLC recalls Piperacillin and Tazobactam for Injection USP 3.375 grams per vial, Single-Dose Vial, Rx Only. Manufactured for: Auromed
Hazard: Presence of Particulate Matter: identified as glass and silicone material
May 23, 2018DrugsFDA
AuroMedics Pharma LLC recalls Piperacillin and Tazobactam for Injection, USP 3.375 grams per vial, For Intravenous Use Only, Single-Dose vial, Rx Only
Hazard: Presence of Particulate Matter: confirmed customer report for presence of visible particulate matter, confirmed as glass
May 16, 2018DrugsFDA
AuroMedics Pharma LLC recalls Ampicillin and Sulbactam for Injection, USP, 3 gram*s/vial, For Intramuscular or Intravenous Use, Sterile, Manufactured
Hazard: 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 ingredients.
May 9, 2018DrugsFDA
AuroMedics Pharma LLC recalls Levofloxacin in 5% Dextrose Injection, 750 mg Levofloxacin (5 mg/mL) in 150 mL of 5% Dextrose, For Intravenous Infusion,
Hazard: Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
May 9, 2018DrugsFDA
AuroMedics Pharma LLC recalls Levofloxacin in 5% Dextrose Injection, 500 mg Levofloxacin (5 mg/mL) in 100 mL of 5% Dextrose, For Intravenous Infusion,
Hazard: Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
May 9, 2018DrugsFDA
AuroMedics Pharma LLC recalls Levetiracetam in 0.54% Sodium Chloride Injection, 1,500 mg per 100 mL (15 mg/mL), For Intravenous Infusion Only, Distrib
Hazard: Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
May 9, 2018DrugsFDA
AuroMedics Pharma LLC recalls Levetiracetam in 0.75% Sodium Chloride Injection, 1000 mg per 100 mL (10 mg/mL), For Intravenous Infusion Only, Distribu
Hazard: Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap