Auromedics Pharma recalls

Auromedics Pharma appears in 36 official U.S. recall notices indexed by RecallRadar, most recently on 2022-11-02.

Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.

Recall summary

Recalls

• Fondaparinux Sodium Injection, USP, 7.5 mg per 0.6 mL, Single Dose, Prefilled Syringe, Distributed by: AuroMedics Pharma LLC 279 Princeton-…
  FDA Drug · Class II · 2022-11-02 · Auromedics Pharma
  Reason: Subpotent Drug: Out of specification for assay
• Acyclovir Sodium Injection, 500mg/10mL (50mg/mL), 10 mL Single Dose Vial, Rx only, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hig…
  FDA Drug · Class II · 2022-10-26 · Auromedics Pharma
  Reason: Presence of Particulate Matter: Customer complaint for a dark red, brown and black particulate floating inside vial.
• Tranexamic Acid Injection, USP, 1000mg per 10 mL (100mg /mL), 10mL single-dose vial, Rx Only, Distributed by: AuroMedics Pharma LLC E. Wind…
  FDA Drug · Class III · 2022-10-12 · Auromedics Pharma
  Reason: Presence of Particulate Matter: Piece of metal found in a vial
• Polymyxin B for Injection USP, 500,000 Units per Vial, 10 mL vials, packaged in 10 vials per carton, Sterile, Rx Only, Distributed by: Auro…
  FDA Drug · Class I · 2022-02-16 · Auromedics Pharma
  Reason: Presence of Particulate Matter; product complaint of hair discovered in a vial within the lot
• Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose Vial, For Intravenous Use Only, Distributed by: AuroMedics Pharm…
  FDA Drug · Class II · 2021-02-10 · Auromedics Pharma
  Reason: Discoloration and failed pH specifications
• Glycopyrrolate Injection, USP 4 mg per 20 mL (0.2 mg/mL), 20 mL Multiple Dose Vial, Rx Only, For Intramuscular or Intravenous Use, Not for…
  FDA Drug · Class III · 2020-02-26 · Auromedics Pharma
  Reason: Failed Impurities/Degradation Specifications: elevated levels of Benzaldehyde impurity was found in investigative samples (retain samples).
• Amoxicillin and Clavulanate Potassium Tablets, USP, 875 mg/125 mg, 20-count bottles, Distributed by: Aurobindo Pharma USA. Inc. 279 Princet…
  FDA Drug · Class II · 2020-02-19 · Auromedics Pharma
  Reason: Presence of Foreign Substance: Customer complaint of a foreign substance identified as nylon cable tie
• Moxifloxacin Ophthalmic Solution USP, 0.5%, Sterile, 3mL Bottle, Rx Only, For Topical Ophthalmic Use Only, Distributed by: Aurobindo Pharma…
  FDA Drug · Class III · 2020-01-22 · Auromedics Pharma
  Reason: Discoloration: Market complaints of discoloration in Moxifloxacin Ophthalmic Solution.
• Gabapentin Capsules, USP 100 mg, Rx Only, Distributed by: Aurobindo Pharma USA, Inc
  FDA Drug · Class II · 2019-12-25 · Auromedics Pharma
  Reason: Presence of Foreign Tablets/Capsules: One Losartan/HCTZ tablet was found in Gabapentin 1000 count bottles..
• Vancomycin Hydrochloride for Injection, USP, 1 g* per vial, packaged in 10-count vials per carton, Rx only, Mft. in India for: AuroMedics P…
  FDA Drug · Class II · 2019-12-18 · Auromedics Pharma
  Reason: Discoloration: Product complaints of discoloration after reconstitution of vials.
• Mirtazapine Tablets, USP, 15 mg, 500-count tablets, Rx only, Distributed by: Aurobindo Pharma USA, Inc
  FDA Drug · Class I · 2019-12-18 · Auromedics Pharma
  Reason: 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.
• Mirtazapine Tablets, USP, 7.5 mg, 500-count tablets, Rx only, Distributed by: Aurobindo Pharma USA, Inc
  FDA Drug · Class I · 2019-12-18 · Auromedics Pharma
  Reason: 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.
• Fluphenazine Decanoate Injection USP 125mg/5mL, (5 mL Multiple Dose Vial), Rx only, For IM or SC Use, Mfd in India for: AuroMedics Pharma,…
  FDA Drug · Class II · 2019-12-11 · Auromedics Pharma
  Reason: Discoloration; Hazy solution found in one vial instead of a clear solution.
• Aurobindo Ranitidine Caspules 150 mg, 60-count bottle, Rx Only Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road Eas…
  FDA Drug · Class II · 2019-12-04 · Auromedics Pharma
  Reason: CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
• Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg/5mL) 474 mL bottle, Rx only Distributed by: Aurobindo Pharma USA Inc. 279…
  FDA Drug · Class II · 2019-12-04 · Auromedics Pharma
  Reason: CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
• Aurobindo Ranitidine Capsules 150 mg, 500 count bottle, Rx Only Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road Ea…
  FDA Drug · Class II · 2019-12-04 · Auromedics Pharma
  Reason: CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
• Amiodarone Hydrochloride Injection, USP, 900 mg per 18 mL (50 mg / mL), 18 mL Multiple Dose Vial, Rx only, Distributed by AuroMedics Pharma…
  FDA Drug · Class III · 2019-12-04 · Auromedics Pharma
  Reason: Crystallization: Presence of visible particulate matter.
• Lidocaine HCl Injection, USP, 2% 100 mg/5 mL (20 mg/mL), Preservative-Free, packaged in 10 x 5 mL Single Dose Vials per carton, Rx only, Di…
  FDA Drug · Class II · 2019-12-04 · Auromedics Pharma
  Reason: Presence of Foreign Substance: Foreign material found inside the vial.
• Amiodarone Hydrochloride Injection, USP, 150 mg per 3 mL (50 mg / mL), 3 mL Single Dose Vial, Rx only, Distributed by AuroMedics Pharma LLC…
  FDA Drug · Class III · 2019-12-04 · Auromedics Pharma
  Reason: Crystallization: Presence of visible particulate matter.
• Amiodarone Hydrochloride Injection, USP, 450 mg per 9 mL (50 mg / mL), 9 mL Single Dose Vial, Rx only, Distributed by AuroMedics Pharma LLC…
  FDA Drug · Class III · 2019-12-04 · Auromedics Pharma
  Reason: Crystallization: Presence of visible particulate matter.
• DG Health Acid Reducer Ranitidine Tablets 150 mg, 8-count carton, Distributed by: Dolgencorp LLC 100 Mission Ridge Goodletville TN 37072 ND…
  FDA Drug · Class II · 2019-12-04 · Auromedics Pharma
  Reason: CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
• Aurobindo Ranitidine Capsules 300 mg, 30-count bottle, Rx Only Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road Eas…
  FDA Drug · Class II · 2019-12-04 · Auromedics Pharma
  Reason: CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
• Ranitidine Tablets USP,150 mg, 8-count bottles, Distributed by: Dolgencorp, LLC, 100 Mission Ridge, Goodlettsville, TN 37073 Made in India…
  FDA Drug · Class III · 2019-11-06 · Auromedics Pharma
  Reason: CGMP DEVIATIONS: One lot of Ranitidine Tablets USP, 150 mg is being recalled because some bottles were empty.
• Piperacillin and Tazobactam for Injection USP 3.375 grams per vial, Single-Dose Vial, Rx Only
  FDA Drug · Class I · 2018-07-18 · Auromedics Pharma
  Reason: Presence of Particulate Matter: identified as glass and silicone material
• Piperacillin and Tazobactam for Injection, USP 3.375 grams per vial, For Intravenous Use Only, Single-Dose vial, Rx Only, Manufactured for:…
  FDA Drug · Class I · 2018-05-23 · Auromedics Pharma
  Reason: Presence of Particulate Matter: confirmed customer report for presence of visible particulate matter, confirmed as glass
• Ampicillin and Sulbactam for Injection, USP, 3 gram*s/vial, For Intramuscular or Intravenous Use, Sterile, Manufactured for: AuroMedics Pha…
  FDA Drug · Class I · 2018-05-16 · Auromedics Pharma
  Reason: 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.
• Levofloxacin in 5% Dextrose Injection, 500 mg Levofloxacin (5 mg/mL) in 100 mL of 5% Dextrose, For Intravenous Infusion, Rx only, Manufactu…
  FDA Drug · Class II · 2018-05-09 · Auromedics Pharma
  Reason: Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
• Levetiracetam in 0.82% Sodium Chloride Injection, 500 mg per 100 mL (5 mg/mL), For Intravenous Infusion Only, Distributed By: AuroMedics Ph…
  FDA Drug · Class II · 2018-05-09 · Auromedics Pharma
  Reason: Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
• Levofloxacin in 5% Dextrose Injection, 250 mg Levofloxacin (5 mg/mL) in 50 mL of 5% Dextrose, For Intravenous Infusion, Rx only, Manufactur…
  FDA Drug · Class II · 2018-05-09 · Auromedics Pharma
  Reason: Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
• Linezolid Injection 600 mg per 300 mL (2 mg/mL) For Intravenous Administration, Rx only, Manufactured By: Aurobindo Pharma Limited IDA Pash…
  FDA Drug · Class II · 2018-05-09 · Auromedics Pharma
  Reason: Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
• Levetiracetam in 0.75% Sodium Chloride Injection, 1000 mg per 100 mL (10 mg/mL), For Intravenous Infusion Only, Distributed By: AuroMedics…
  FDA Drug · Class II · 2018-05-09 · Auromedics Pharma
  Reason: Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
• Levofloxacin in 5% Dextrose Injection, 750 mg Levofloxacin (5 mg/mL) in 150 mL of 5% Dextrose, For Intravenous Infusion, Rx only, Manufactu…
  FDA Drug · Class II · 2018-05-09 · Auromedics Pharma
  Reason: Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
• Levetiracetam in 0.54% Sodium Chloride Injection, 1,500 mg per 100 mL (15 mg/mL), For Intravenous Infusion Only, Distributed By: AuroMedics…
  FDA Drug · Class II · 2018-05-09 · Auromedics Pharma
  Reason: Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
• Levofloxacin in 5% Dextrose Injection, 250 mg/50 mL (5 mg/mL), 50 mL Single-Use flexible container, Rx Only, Manufactured for: AuroMedics P…
  FDA Drug · Class I · 2018-03-07 · Auromedics Pharma
  Reason: Presence of Particulate Matter; contains visible particulate matter identified as mold.
• Linezolid Injection 600 mg/300 mL (2 mg/mL), 300 mL Single-use, ready-to-use flexible plastic infusion bags in a foil laminate overwrap, Rx…
  FDA Drug · Class I · 2018-02-14 · Auromedics Pharma
  Reason: Presence of Particulate Matter; white particulate matter identified as mold was found in one bag
• Pantoprazole Sodium for Injection, 40 mg per vial, single dose vial, Rx only, Manufactured in India for: AuroMedics Pharma LLC, 6 Wheeling…
  FDA Drug · Class I · 2018-02-14 · Auromedics Pharma
  Reason: Presence of Particulate Matter: One vial from a lot of Pantoprazole Sodium for Injection (40 mg) contained a piece of glass