AuroMedics Pharma recalls

AuroMedics Pharma has 36 recalls on record with the FDA and USDA, the earliest in 2018 and the latest reported on 2 Nov 2022. 7 are still ongoing. The most frequent reason is particulate matter.

Total recalls36since 2018

Last 12 months0reported

Class I925% of total

Ongoing7latest 2 Nov 2022

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 0May 0 0 0Aug 0 0 0Nov 0 0 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

Class I 9 25%Class II 20 56%Class III 7 19%

Why auromedics pharma is recalled

Product types

Brands

By year

2022411%
202113%
202038%
20191542%
20181336%

Ongoing auromedics pharma recalls

7 active

Reported	Class	Recall	Company	Reason	Where
12 Oct 2022Drug	CLASS III	Tranexamic Acid Injection, USP, 1000mg recalled by AuroMedics PharmaTranexamic Acid	AuroMedics Pharma	Particulate Matter	Nationwide
4 Dec 2019Drug	CLASS II	DG Health Acid Reducer Ranitidine Tablets 150 mg recalled	AuroMedics Pharma	Nitrosamine Impurity	Nationwide
4 Dec 2019Drug	CLASS II	Aurobindo Ranitidine Capsules 150 mg recalled by AuroMedics Pharma	AuroMedics Pharma	Nitrosamine Impurity	Nationwide
4 Dec 2019Drug	CLASS II	Aurobindo Ranitidine Caspules 150 mg recalled by AuroMedics Pharma	AuroMedics Pharma	Nitrosamine Impurity	Nationwide
4 Dec 2019Drug	CLASS II	Aurobindo Ranitidine Capsules 300 mg recalled by AuroMedics Pharma	AuroMedics Pharma	Nitrosamine Impurity	Nationwide
4 Dec 2019Drug	CLASS II	Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg recalled	AuroMedics Pharma	Nitrosamine Impurity	Nationwide

All auromedics pharma recalls, newest first

36 total

Reported	Class	Recall	Company	Reason	Where
2 Nov 2022Drug	CLASS II	Fondaparinux Sodium Injection, USP, 7.5 mg per, Single Dose recalledFondaparinux Sodium	AuroMedics Pharma	Potency & Assay	Nationwide
26 Oct 2022Drug	CLASS II	Acyclovir Sodium Injection, 500mg/ (50mg/mL) Single Dose Vial recalledAcyclovir Sodium	AuroMedics Pharma	Particulate Matter	Nationwide
12 Oct 2022Drug	CLASS III	Tranexamic Acid Injection, USP, 1000mg recalled by AuroMedics PharmaTranexamic Acid	AuroMedics Pharma	Particulate Matter	Nationwide
16 Feb 2022Drug	CLASS I	Polymyxin B for Injection USP per Vial vials recalledPolymyxin B	AuroMedics Pharma	Particulate Matter	Nationwide
10 Feb 2021Drug	CLASS II	Acetaminophen Injection 1,000 mg recalled by AuroMedics PharmaAcetaminophen	AuroMedics Pharma	Other	Nationwide
26 Feb 2020Drug	CLASS III	Glycopyrrolate Injection, USP 4 mg recalled by AuroMedics PharmaGlycopyrrolate	AuroMedics Pharma	Potency & Assay	LA, MS, OH
19 Feb 2020Drug	CLASS II	Amoxicillin and Clavulanate Potassium Tablets, USP, 875 mg/125 mg recalled	AuroMedics Pharma	Other	Nationwide
22 Jan 2020Drug	CLASS III	Moxifloxacin Ophthalmic Solution USP, 0.5%, Sterile recalled	AuroMedics Pharma	Other	Nationwide
25 Dec 2019Drug	CLASS II	Gabapentin Capsules, USP 100 mg recalled by AuroMedics Pharma	AuroMedics Pharma	Other	Nationwide
18 Dec 2019Drug	CLASS I	Mirtazapine Tablets recalled by AuroMedics PharmaMirtazapine	AuroMedics Pharma	Other	Nationwide
18 Dec 2019Drug	CLASS I	Mirtazapine Tablets recalled by AuroMedics PharmaMirtazapine	AuroMedics Pharma	Other	Nationwide
18 Dec 2019Drug	CLASS II	Vancomycin Hydrochloride for Injection, USP* per vial recalledVancomycin Hydrochloride	AuroMedics Pharma	Packaging Defects	Nationwide
11 Dec 2019Drug	CLASS II	Fluphenazine Decanoate Injection USP 125mg/ Multiple Dose Vial) recalled	AuroMedics Pharma	Other	Nationwide
4 Dec 2019Drug	CLASS II	DG Health Acid Reducer Ranitidine Tablets 150 mg recalled	AuroMedics Pharma	Nitrosamine Impurity	Nationwide
4 Dec 2019Drug	CLASS III	Amiodarone Hydrochloride Injection, USP, 900 mg recalledAmiodarone Hydrochloride	AuroMedics Pharma	Particulate Matter	Nationwide
4 Dec 2019Drug	CLASS II	Aurobindo Ranitidine Capsules 150 mg recalled by AuroMedics Pharma	AuroMedics Pharma	Nitrosamine Impurity	Nationwide
4 Dec 2019Drug	CLASS II	Aurobindo Ranitidine Caspules 150 mg recalled by AuroMedics Pharma	AuroMedics Pharma	Nitrosamine Impurity	Nationwide
4 Dec 2019Drug	CLASS II	Lidocaine HCl Injection, USP, 2% 100 mg/ (20 mg/mL) recalledMarlido Kit	AuroMedics Pharma	Foreign Material	Nationwide
4 Dec 2019Drug	CLASS II	Aurobindo Ranitidine Capsules 300 mg recalled by AuroMedics Pharma	AuroMedics Pharma	Nitrosamine Impurity	Nationwide
4 Dec 2019Drug	CLASS III	Amiodarone Hydrochloride Injection, USP, 450 mg recalledAmiodarone Hydrochloride	AuroMedics Pharma	Particulate Matter	Nationwide
4 Dec 2019Drug	CLASS III	Amiodarone Hydrochloride Injection, USP, 150 mg recalledAmiodarone Hydrochloride	AuroMedics Pharma	Particulate Matter	Nationwide
4 Dec 2019Drug	CLASS II	Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg recalled	AuroMedics Pharma	Nitrosamine Impurity	Nationwide
6 Nov 2019Drug	CLASS III	Ranitidine Tablets USP,150 mg recalled by AuroMedics Pharma	AuroMedics Pharma	Manufacturing (CGMP) Deviations	Nationwide
18 Jul 2018Drug	CLASS I	Piperacillin and Tazobactam for Injection USP per vial recalledPiperacillin And Tazobactam	AuroMedics Pharma	Particulate Matter	Nationwide
23 May 2018Drug	CLASS I	Piperacillin and Tazobactam for Injection, USP per vial recalledPiperacillin And Tazobactam	AuroMedics Pharma	Particulate Matter	Nationwide
16 May 2018Drug	CLASS I	Ampicillin and Sulbactam for Injection, USP*s/vial recalledAmpicillin And Sulbactam	AuroMedics Pharma	Particulate Matter	Nationwide
9 May 2018Drug	CLASS II	Levetiracetam in 0.75% Sodium Chloride Injection recalledLevetiracetam	AuroMedics Pharma	Mold	Nationwide
9 May 2018Drug	CLASS II	Linezolid Injection 600 mg recalled by AuroMedics PharmaLinezolid	AuroMedics Pharma	Mold	Nationwide
9 May 2018Drug	CLASS II	Levofloxacin in 5% Dextrose Injection, 500 mg Levofloxacin recalledLevofloxacin	AuroMedics Pharma	Mold	Nationwide
9 May 2018Drug	CLASS II	Levofloxacin in 5% Dextrose Injection, 250 mg Levofloxacin recalledLevofloxacin	AuroMedics Pharma	Mold	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.