AuroMedics Pharma LLC
Complete recall history across all FDA and CPSC categories — 36 total recalls
AuroMedics Pharma LLC appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Drug Recalls (36)
FDA drug safety enforcement actions by AuroMedics Pharma LLC
| Date | Product | Reason | Class |
|---|---|---|---|
| Sep 30, 2022 | Fondaparinux Sodium Injection, USP, 7.5 mg per 0.6 mL, Single Dose, Prefilled... | Subpotent Drug: Out of specification for assay | Class II |
| Sep 26, 2022 | Acyclovir Sodium Injection, 500mg/10mL (50mg/mL), 10 mL Single Dose Vial, Rx ... | Presence of Particulate Matter: Customer complaint for a dark red, brown and ... | Class II |
| Sep 26, 2022 | Tranexamic Acid Injection, USP, 1000mg per 10 mL (100mg /mL), 10mL single-dos... | Presence of Particulate Matter: Piece of metal found in a vial | Class III |
| Jan 26, 2022 | Polymyxin B for Injection USP, 500,000 Units per Vial, 10 mL vials, packaged ... | Presence of Particulate Matter; product complaint of hair discovered in a via... | Class I |
| Dec 30, 2020 | Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose Vi... | Discoloration and failed pH specifications | Class II |
| Feb 7, 2020 | Glycopyrrolate Injection, USP 4 mg per 20 mL (0.2 mg/mL), 20 mL Multiple Dose... | Failed Impurities/Degradation Specifications: elevated levels of Benzaldehyde... | Class III |
| Feb 7, 2020 | Amoxicillin and Clavulanate Potassium Tablets, USP, 875 mg/125 mg, 20-count b... | Presence of Foreign Substance: Customer complaint of a foreign substance iden... | Class II |
| Dec 2, 2019 | Moxifloxacin Ophthalmic Solution USP, 0.5%, Sterile, 3mL Bottle, Rx Only, For... | Discoloration: Market complaints of discoloration in Moxifloxacin Ophthalmic ... | Class III |
| Nov 25, 2019 | Vancomycin Hydrochloride for Injection, USP, 1 g* per vial, packaged in 10-co... | Discoloration: Product complaints of discoloration after reconstitution of vi... | Class II |
| Nov 20, 2019 | Mirtazapine Tablets, USP, 7.5 mg, 500-count tablets, Rx only, Distributed by... | Labeling: Label Error on Declared Strength; cases labelled Mirtazapine 15mg t... | Class I |
| Nov 20, 2019 | Mirtazapine Tablets, USP, 15 mg, 500-count tablets, Rx only, Distributed by:... | Labeling: Label Error on Declared Strength; cases labelled Mirtazapine 15mg t... | Class I |
| Nov 19, 2019 | Gabapentin Capsules, USP 100 mg, Rx Only, Distributed by: Aurobindo Pharma US... | Presence of Foreign Tablets/Capsules: One Losartan/HCTZ tablet was found in ... | Class II |
| Nov 12, 2019 | Fluphenazine Decanoate Injection USP 125mg/5mL, (5 mL Multiple Dose Vial), Rx... | Discoloration; Hazy solution found in one vial instead of a clear solution. | Class II |
| Nov 11, 2019 | Amiodarone Hydrochloride Injection, USP, 900 mg per 18 mL (50 mg / mL), 18 mL... | Crystallization: Presence of visible particulate matter. | Class III |
| Nov 11, 2019 | Lidocaine HCl Injection, USP, 2% 100 mg/5 mL (20 mg/mL), Preservative-Free, p... | Presence of Foreign Substance: Foreign material found inside the vial. | Class II |
| Nov 11, 2019 | Amiodarone Hydrochloride Injection, USP, 450 mg per 9 mL (50 mg / mL), 9 mL S... | Crystallization: Presence of visible particulate matter. | Class III |
| Nov 11, 2019 | Amiodarone Hydrochloride Injection, USP, 150 mg per 3 mL (50 mg / mL), 3 mL S... | Crystallization: Presence of visible particulate matter. | Class III |
| Nov 6, 2019 | DG Health Acid Reducer Ranitidine Tablets 150 mg, 8-count carton, Distributed... | CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidin... | Class II |
| Nov 6, 2019 | Aurobindo Ranitidine Capsules 150 mg, 500 count bottle, Rx Only Distributed b... | CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidin... | Class II |
| Nov 6, 2019 | Aurobindo Ranitidine Caspules 150 mg, 60-count bottle, Rx Only Distributed by... | CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidin... | Class II |
| Nov 6, 2019 | Aurobindo Ranitidine Capsules 300 mg, 30-count bottle, Rx Only Distributed by... | CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidin... | Class II |
| Nov 6, 2019 | Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg/5mL) 474 mL... | CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidin... | Class II |
| Sep 23, 2019 | Ranitidine Tablets USP,150 mg, 8-count bottles, Distributed by: Dolgencorp,... | CGMP DEVIATIONS: One lot of Ranitidine Tablets USP, 150 mg is being recalled ... | Class III |
| Jul 2, 2018 | Piperacillin and Tazobactam for Injection USP 3.375 grams per vial, Single-Do... | Presence of Particulate Matter: identified as glass and silicone material | Class I |
| May 1, 2018 | Piperacillin and Tazobactam for Injection, USP 3.375 grams per vial, For Intr... | Presence of Particulate Matter: confirmed customer report for presence of vis... | Class I |
| May 1, 2018 | Ampicillin and Sulbactam for Injection, USP, 3 gram*s/vial, For Intramuscular... | Presence of Particulate Matter: confirmed customer report of the presence of ... | Class I |
| Mar 27, 2018 | Levetiracetam in 0.75% Sodium Chloride Injection, 1000 mg per 100 mL (10 mg/m... | Lack of Assurance of Sterility; confirmed customer report of a leaking bags a... | Class II |
| Mar 27, 2018 | Linezolid Injection 600 mg per 300 mL (2 mg/mL) For Intravenous Administratio... | Lack of Assurance of Sterility; confirmed customer report of a leaking bags a... | Class II |
| Mar 27, 2018 | Levofloxacin in 5% Dextrose Injection, 500 mg Levofloxacin (5 mg/mL) in 100 m... | Lack of Assurance of Sterility; confirmed customer report of a leaking bags a... | Class II |
| Mar 27, 2018 | Levofloxacin in 5% Dextrose Injection, 250 mg Levofloxacin (5 mg/mL) in 50 mL... | Lack of Assurance of Sterility; confirmed customer report of a leaking bags a... | Class II |
| Mar 27, 2018 | Levetiracetam in 0.82% Sodium Chloride Injection, 500 mg per 100 mL (5 mg/mL)... | Lack of Assurance of Sterility; confirmed customer report of a leaking bags a... | Class II |
| Mar 27, 2018 | Levetiracetam in 0.54% Sodium Chloride Injection, 1,500 mg per 100 mL (15 mg/... | Lack of Assurance of Sterility; confirmed customer report of a leaking bags a... | Class II |
| Mar 27, 2018 | Levofloxacin in 5% Dextrose Injection, 750 mg Levofloxacin (5 mg/mL) in 150 m... | Lack of Assurance of Sterility; confirmed customer report of a leaking bags a... | Class II |
| Jan 12, 2018 | Levofloxacin in 5% Dextrose Injection, 250 mg/50 mL (5 mg/mL), 50 mL Single-U... | Presence of Particulate Matter; contains visible particulate matter identifie... | Class I |
| Dec 20, 2017 | Linezolid Injection 600 mg/300 mL (2 mg/mL), 300 mL Single-use, ready-to-use ... | Presence of Particulate Matter; white particulate matter identified as mold w... | Class I |
| Dec 4, 2017 | Pantoprazole Sodium for Injection, 40 mg per vial, single dose vial, Rx only,... | Presence of Particulate Matter: One vial from a lot of Pantoprazole Sodium fo... | Class I |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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