AuroMedics Pharma recalls
FDA enforcement reports naming AuroMedics Pharma LLC as the recalling firm.
- Recall reports
- 36
- Class I (serious)
- 9
- Most recent report
- Nov 2, 2022
- Nov 2, 2022Fondaparinux Sodium Injection, USP, 7Drug · AuroMedics Pharma LLCSubpotent Drug: Out of specification for assayClass II
- Oct 26, 2022Acyclovir Sodium Injection, 500mg/10mL (50mg/mL), 10 mL Single Dose Vial, Rx only, Dist…Drug · AuroMedics Pharma LLCPresence of Particulate Matter: Customer complaint for a dark red, brown and black particulate floating inside vial.Class II
- Oct 12, 2022Tranexamic Acid Injection, USP, 1000mg per 10 mL (100mg /mL), 10mL single-dose vial, Rx…Drug · AuroMedics Pharma LLCPresence of Particulate Matter: Piece of metal found in a vialClass III
- Feb 16, 2022Polymyxin B for Injection USP, 500,000 Units per Vial, 10 mL vials, packaged in 10 vial…Drug · AuroMedics Pharma LLCPresence of Particulate Matter; product complaint of hair discovered in a vial within the lotClass I
- Feb 10, 2021Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose Vial, For In…Drug · AuroMedics Pharma LLCDiscoloration and failed pH specificationsClass II
- Feb 26, 2020Glycopyrrolate Injection, USP 4 mg per 20 mL (0Drug · AuroMedics Pharma LLCFailed Impurities/Degradation Specifications: elevated levels of Benzaldehyde impurity was found in investigative samples (retain samples).Class III
- Feb 19, 2020Amoxicillin and Clavulanate Potassium Tablets, USP, 875 mg/125 mg, 20-count bottles, Di…Drug · AuroMedics Pharma LLCPresence of Foreign Substance: Customer complaint of a foreign substance identified as nylon cable tieClass II
- Jan 22, 2020Moxifloxacin Ophthalmic Solution USP, 0Drug · AuroMedics Pharma LLCDiscoloration: Market complaints of discoloration in Moxifloxacin Ophthalmic Solution.Class III
- Dec 25, 2019Gabapentin Capsules, USP 100 mg, Rx Only, Distributed by: Aurobindo Pharma USA, IncDrug · AuroMedics Pharma LLCPresence of Foreign Tablets/Capsules: One Losartan/HCTZ tablet was found in Gabapentin 1000 count bottles..Class II
- Dec 18, 2019Vancomycin Hydrochloride for Injection, USP, 1 g* per vial, packaged in 10-count vials…Drug · AuroMedics Pharma LLCDiscoloration: Product complaints of discoloration after reconstitution of vials.Class II
- Mirtazapine Tablets, USP, 7
- Mirtazapine Tablets, USP, 15 mg, 500-count tablets, Rx only, Distributed by: Aurobindo…
- Fluphenazine Decanoate Injection USP 125mg/5mL, (5 mL Multiple Dose Vial), Rx only, For…
- Aurobindo Ranitidine Capsules 300 mg, 30-count bottle, Rx Only Distributed by: Aurobind…
- Amiodarone Hydrochloride Injection, USP, 150 mg per 3 mL (50 mg / mL), 3 mL Single Dose…
- Amiodarone Hydrochloride Injection, USP, 450 mg per 9 mL (50 mg / mL), 9 mL Single Dose…
- Amiodarone Hydrochloride Injection, USP, 900 mg per 18 mL (50 mg / mL), 18 mL Multiple…
- Aurobindo Ranitidine Caspules 150 mg, 60-count bottle, Rx Only Distributed by: Aurobind…
- Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg/5mL) 474 mL bottle, R…
- Aurobindo Ranitidine Capsules 150 mg, 500 count bottle, Rx Only Distributed by: Aurobin…
- Lidocaine HCl Injection, USP, 2% 100 mg/5 mL (20 mg/mL), Preservative-Free, packaged in…
- DG Health Acid Reducer Ranitidine Tablets 150 mg, 8-count carton, Distributed by: Dolge…
- Ranitidine Tablets USP,150 mg, 8-count bottles, Distributed by: Dolgencorp, LLC, 100…
- Piperacillin and Tazobactam for Injection USP 3
- Piperacillin and Tazobactam for Injection, USP 3
- Ampicillin and Sulbactam for Injection, USP, 3 gram*s/vial, For Intramuscular or Intrav…
- Levetiracetam in 0
- Levofloxacin in 5% Dextrose Injection, 250 mg Levofloxacin (5 mg/mL) in 50 mL of 5% Dex…
- Levetiracetam in 0
- Levofloxacin in 5% Dextrose Injection, 750 mg Levofloxacin (5 mg/mL) in 150 mL of 5% De…
- Levofloxacin in 5% Dextrose Injection, 500 mg Levofloxacin (5 mg/mL) in 100 mL of 5% De…
- Levetiracetam in 0
- Linezolid Injection 600 mg per 300 mL (2 mg/mL) For Intravenous Administration, Rx only…
- Levofloxacin in 5% Dextrose Injection, 250 mg/50 mL (5 mg/mL), 50 mL Single-Use flexibl…
- Pantoprazole Sodium for Injection, 40 mg per vial, single dose vial, Rx only, Manufactu…
- Linezolid Injection 600 mg/300 mL (2 mg/mL), 300 mL Single-use, ready-to-use flexible p…
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