AuroMedics Pharma LLC recalls

42 recalls on record · latest: September 30, 2022

Official U.S. recall history for AuroMedics Pharma LLC, compiled from official government records.

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AuroMedics Pharma LLC recalls Fondaparinux Sodium Injection, USP, 7.5 mg per 0.6 mL, Single Dose, Prefilled Syringe, Distributed by: AuroMedics Pharm…

September 30, 2022 · Drug & medication recalls Moderate risk Subpotent Drug: Out of specification for assay

Tranexamic Acid Injection recalled over possible metal fragments

September 26, 2022 · Drug & medication recalls Presence of Particulate Matter: Piece of metal found in a vial

AuroMedics Pharma LLC recalls Acyclovir Sodium Injection, 500mg/10mL (50mg/mL), 10 mL Single Dose Vial, Rx only, Distributed by: AuroMedics Pharma LL…

September 26, 2022 · Drug & medication recalls Moderate risk Presence of Particulate Matter: Customer complaint for a dark red, brown and bl…

Polymyxin B for Injection USP recalled over foreign material

January 28, 2022 · Drug & medication recalls Presence of Particulate Matter — Potential Foreign Material

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,…

January 26, 2022 · Drug & medication recalls High risk Presence of Particulate Matter; product complaint of hair discovered in a vial…

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…

December 30, 2020 · Drug & medication recalls Moderate risk Discoloration and failed pH specifications

AuroMedics Pharma LLC recalls Amoxicillin and Clavulanate Potassium Tablets, USP, 875 mg/125 mg, 20-count bottles, Distributed by: Aurobindo Pharma U…

February 7, 2020 · Drug & medication recalls Moderate risk Presence of Foreign Substance: Customer complaint of a foreign substance identi…

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 Intra…

February 7, 2020 · Drug & medication recalls Failed Impurities/Degradation Specifications: elevated levels of Benzaldehyde i…

AuroMedics Pharma LLC recalls Moxifloxacin Ophthalmic Solution USP, 0.5%, Sterile, 3mL Bottle, Rx Only, For Topical Ophthalmic Use Only, Distributed…

December 2, 2019 · Drug & medication recalls Discoloration: Market complaints of discoloration in Moxifloxacin Ophthalmic So…

AuroMedics Pharma LLC recalls Vancomycin Hydrochloride for Injection, USP, 1 g* per vial, packaged in 10-count vials per carton, Rx only, Mft. in Ind…

November 25, 2019 · Drug & medication recalls Moderate risk Discoloration: Product complaints of discoloration after reconstitution of vial…

AuroMedics Pharma LLC recalls Mirtazapine Tablets, USP, 15 mg, 500-count tablets, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 0881…

November 20, 2019 · Drug & medication recalls High risk Labeling: Label Error on Declared Strength; cases labelled Mirtazapine 15mg tab…

AuroMedics Pharma LLC recalls Mirtazapine Tablets, USP, 7.5 mg, 500-count tablets, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 088…

November 20, 2019 · Drug & medication recalls High risk Labeling: Label Error on Declared Strength; cases labelled Mirtazapine 15mg tab…

AuroMedics Pharma LLC recalls Gabapentin Capsules, USP 100 mg, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 65682-198-99

November 19, 2019 · Drug & medication recalls Moderate risk Presence of Foreign Tablets/Capsules: One Losartan/HCTZ tablet was found in Gab…

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:…

November 12, 2019 · Drug & medication recalls Moderate risk Discoloration; Hazy solution found in one vial instead of a clear solution.

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 A…

November 11, 2019 · Drug & medication recalls Crystallization: Presence of visible particulate matter.

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 A…

November 11, 2019 · Drug & medication recalls Crystallization: Presence of visible particulate matter.

Lidocaine HCl Injection recalled over foreign material

November 11, 2019 · Drug & medication recalls Moderate risk Presence of Foreign Substance: Foreign material found inside the vial.

AuroMedics Pharma LLC recalls Amiodarone Hydrochloride Injection, USP, 900 mg per 18 mL (50 mg / mL), 18 mL Multiple Dose Vial, Rx only, Distributed…

November 11, 2019 · Drug & medication recalls Crystallization: Presence of visible particulate matter.

Ranitidine Syrup recalled over manufacturing violations

November 6, 2019 · Drug & medication recalls Moderate risk CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine…

Aurobindo Ranitidine Capsules 300 mg recalled over manufacturing violations

November 6, 2019 · Drug & medication recalls Moderate risk CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine…

Aurobindo Ranitidine Caspules 150 mg recalled over manufacturing violations

November 6, 2019 · Drug & medication recalls Moderate risk CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine…

Aurobindo Ranitidine Capsules 150 mg recalled over manufacturing violations

November 6, 2019 · Drug & medication recalls Moderate risk CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine…

DG Health Acid Reducer Ranitidine Tablets 150 mg recalled over manufacturing violations

November 6, 2019 · Drug & medication recalls Moderate risk CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine…

Ranitidine Tablets USP recalled over manufacturing violations

September 23, 2019 · Drug & medication recalls CGMP DEVIATIONS: One lot of Ranitidine Tablets USP, 150 mg is being recalled be…

AuroMedics Pharma LLC recalls Piperacillin and Tazobactam for Injection USP 3.375 grams per vial, Single-Dose Vial, Rx Only. Manufactured for: Aurome…

July 2, 2018 · Drug & medication recalls High risk Presence of Particulate Matter: identified as glass and silicone material

Piperacillin and Tazobactam for injection recalled over foreign material

May 14, 2018 · Drug & medication recalls Due to Presence of Glass Particulates — Potential Foreign Material

Ampicillin and Sulbactam for Injection USP recalled over foreign material

May 14, 2018 · Drug & medication recalls Visible Particulate Matter — Potential Foreign Material

AuroMedics Pharma LLC recalls Ampicillin and Sulbactam for Injection, USP, 3 gram*s/vial, For Intramuscular or Intravenous Use, Sterile, Manufactured…

May 1, 2018 · Drug & medication recalls High risk Presence of Particulate Matter: confirmed customer report of the presence of vi…

AuroMedics Pharma LLC recalls Piperacillin and Tazobactam for Injection, USP 3.375 grams per vial, For Intravenous Use Only, Single-Dose vial, Rx Onl…

May 1, 2018 · Drug & medication recalls High risk Presence of Particulate Matter: confirmed customer report for presence of visib…

Levofloxacin in 5% Dextrose Injection recalled over sterility concerns

March 27, 2018 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility; confirmed customer report of a leaking bags and…

Levetiracetam in 0 recalled over sterility concerns

March 27, 2018 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility; confirmed customer report of a leaking bags and…

Levetiracetam in 0 recalled over sterility concerns

March 27, 2018 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility; confirmed customer report of a leaking bags and…

Levofloxacin in 5% Dextrose Injection recalled over sterility concerns

March 27, 2018 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility; confirmed customer report of a leaking bags and…

Levofloxacin in 5% Dextrose Injection recalled over sterility concerns

March 27, 2018 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility; confirmed customer report of a leaking bags and…

Linezolid Injection 600 mg per For Intravenous Administration recalled over sterility concerns

March 27, 2018 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility; confirmed customer report of a leaking bags and…

Levetiracetam in 0 recalled over sterility concerns

March 27, 2018 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility; confirmed customer report of a leaking bags and…

Levofloxacin in 5% Dextrose Injection 250mg/ recalled over foreign material

January 25, 2018 · Drug & medication recalls Due to the Presence of Particulate Matter — Potential Foreign Material

Levofloxacin in 5% Dextrose Injection recalled over mold contamination

January 12, 2018 · Drug & medication recalls High risk Presence of Particulate Matter; contains visible particulate matter identified…

Pantoprazole Sodium for Injection 40 mg per vial recalled over foreign material

December 29, 2017 · Drug & medication recalls Contains glass particles — Potential Foreign Material

Linezolid Injection 600 mg/ recalled over mold contamination

December 20, 2017 · Drug & medication recalls High risk Presence of Particulate Matter; white particulate matter identified as mold was…

Pantoprazole Sodium for Injection recalled over possible glass fragments

December 4, 2017 · Drug & medication recalls High risk Presence of Particulate Matter: One vial from a lot of Pantoprazole Sodium for…