AuroMedics Pharma LLC: 22 recalls on record

Recalls filed with 1 agency: FDA (22).

First recall on record: February 14, 2018. Most recent: November 2, 2022.

Risk classification: Class I: 7 · Class II: 10 · Class III: 5

Most recent recalls

DateAgencyProduct
November 2, 2022FDAFondaparinux Sodium Injection, USP, 7.5 mg per 0.6 mL, Single Dose, Prefilled Syringe, Di…D-0020-2023
October 26, 2022FDAAcyclovir Sodium Injection, 500mg/10mL (50mg/mL), 10 mL Single Dose Vial, Rx only, Distri…D-0013-2023
October 12, 2022FDATranexamic Acid Injection, USP, 1000mg per 10 mL (100mg /mL), 10mL single-dose vial, Rx O…D-1551-2022
February 16, 2022FDAPolymyxin B for Injection USP, 500,000 Units per Vial, 10 mL vials, packaged in 10 vials …D-0556-2022
February 26, 2020FDAGlycopyrrolate Injection, USP 4 mg per 20 mL (0.2 mg/mL), 20 mL Multiple Dose Vial, Rx On…D-0853-2020
February 19, 2020FDAAmoxicillin and Clavulanate Potassium Tablets, USP, 875 mg/125 mg, 20-count bottles, Dist…D-0852-2020
January 22, 2020FDAMoxifloxacin Ophthalmic Solution USP, 0.5%, Sterile, 3mL Bottle, Rx Only, For Topical Oph…D-0789-2020
December 18, 2019FDAMirtazapine Tablets, USP, 15 mg, 500-count tablets, Rx only, Distributed by: Aurobindo P…D-0636-2020
December 18, 2019FDAVancomycin Hydrochloride for Injection, USP, 1 g* per vial, packaged in 10-count vials pe…D-0574-2020
December 11, 2019FDAFluphenazine Decanoate Injection USP 125mg/5mL, (5 mL Multiple Dose Vial), Rx only, For I…D-0609-2020
December 4, 2019FDAAmiodarone Hydrochloride Injection, USP, 150 mg per 3 mL (50 mg / mL), 3 mL Single Dose V…D-0520-2020
December 4, 2019FDARanitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg/5mL) 474 mL bottle, Rx …D-0529-2020
December 4, 2019FDAAmiodarone Hydrochloride Injection, USP, 450 mg per 9 mL (50 mg / mL), 9 mL Single Dose V…D-0521-2020
July 18, 2018FDAPiperacillin and Tazobactam for Injection USP 3.375 grams per vial, Single-Dose Vial, Rx …D-1030-2018
May 16, 2018FDAAmpicillin and Sulbactam for Injection, USP, 3 gram*s/vial, For Intramuscular or Intraven…D-0866-2018
May 9, 2018FDALevetiracetam in 0.54% Sodium Chloride Injection, 1,500 mg per 100 mL (15 mg/mL), For Int…D-0707-2018
May 9, 2018FDALevetiracetam in 0.82% Sodium Chloride Injection, 500 mg per 100 mL (5 mg/mL), For Intrav…D-0705-2018
May 9, 2018FDALevofloxacin in 5% Dextrose Injection, 750 mg Levofloxacin (5 mg/mL) in 150 mL of 5% Dext…D-0709-2018
May 9, 2018FDALevofloxacin in 5% Dextrose Injection, 250 mg Levofloxacin (5 mg/mL) in 50 mL of 5% Dextr…D-0704-2018
March 7, 2018FDALevofloxacin in 5% Dextrose Injection, 250 mg/50 mL (5 mg/mL), 50 mL Single-Use flexible …D-0574-2018
February 14, 2018FDALinezolid Injection 600 mg/300 mL (2 mg/mL), 300 mL Single-use, ready-to-use flexible pla…D-0337-2018
February 14, 2018FDAPantoprazole Sodium for Injection, 40 mg per vial, single dose vial, Rx only, Manufacture…D-0340-2018

Questions about this company

How many recalls does AuroMedics Pharma LLC have?
Recalert has 22 U.S. recalls on record for AuroMedics Pharma LLC, published between February 14, 2018 and November 2, 2022.
What was the most recent AuroMedics Pharma LLC recall?
FDA recall D-0020-2023, published November 2, 2022: Fondaparinux Sodium Injection, USP, 7.5 mg per 0.6 mL, Single Dose, Prefilled Syringe, Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520. Made in India. NDC 5515…
Which agencies have handled AuroMedics Pharma LLC recalls?
AuroMedics Pharma LLC appears as the recalling firm in recalls from: FDA (22).

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