AuroMedics Pharma LLC

FDA Regulatory Profile

Summary

Total Recalls
36 (9 Class I)
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0020-2023Class IIFondaparinux Sodium Injection, USP, 7.5 mg per 0.6 mL, Single Dose, Prefilled Syringe, Distributed bSeptember 30, 2022
D-0013-2023Class IIAcyclovir Sodium Injection, 500mg/10mL (50mg/mL), 10 mL Single Dose Vial, Rx only, Distributed by: ASeptember 26, 2022
D-1551-2022Class IIITranexamic Acid Injection, USP, 1000mg per 10 mL (100mg /mL), 10mL single-dose vial, Rx Only, DistriSeptember 26, 2022
D-0556-2022Class IPolymyxin B for Injection USP, 500,000 Units per Vial, 10 mL vials, packaged in 10 vials per carton,January 26, 2022
D-0248-2021Class IIAcetaminophen Injection 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose Vial, For Intravenous UseDecember 30, 2020
D-0853-2020Class IIIGlycopyrrolate Injection, USP 4 mg per 20 mL (0.2 mg/mL), 20 mL Multiple Dose Vial, Rx Only, For IntFebruary 7, 2020
D-0852-2020Class IIAmoxicillin and Clavulanate Potassium Tablets, USP, 875 mg/125 mg, 20-count bottles, Distributed by:February 7, 2020
D-0789-2020Class IIIMoxifloxacin Ophthalmic Solution USP, 0.5%, Sterile, 3mL Bottle, Rx Only, For Topical Ophthalmic UseDecember 2, 2019
D-0574-2020Class IIVancomycin Hydrochloride for Injection, USP, 1 g* per vial, packaged in 10-count vials per carton, RNovember 25, 2019
D-0636-2020Class IMirtazapine Tablets, USP, 15 mg, 500-count tablets, Rx only, Distributed by: Aurobindo Pharma USA, November 20, 2019
D-0637-2020Class IMirtazapine Tablets, USP, 7.5 mg, 500-count tablets, Rx only, Distributed by: Aurobindo Pharma USA,November 20, 2019
D-0653-2020Class IIGabapentin Capsules, USP 100 mg, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 0881November 19, 2019
D-0609-2020Class IIFluphenazine Decanoate Injection USP 125mg/5mL, (5 mL Multiple Dose Vial), Rx only, For IM or SC UseNovember 12, 2019
D-0522-2020Class IIIAmiodarone Hydrochloride Injection, USP, 900 mg per 18 mL (50 mg / mL), 18 mL Multiple Dose Vial, RxNovember 11, 2019
D-0520-2020Class IIIAmiodarone Hydrochloride Injection, USP, 150 mg per 3 mL (50 mg / mL), 3 mL Single Dose Vial, Rx onlNovember 11, 2019
D-0521-2020Class IIIAmiodarone Hydrochloride Injection, USP, 450 mg per 9 mL (50 mg / mL), 9 mL Single Dose Vial, Rx onlNovember 11, 2019
D-0573-2020Class IILidocaine HCl Injection, USP, 2% 100 mg/5 mL (20 mg/mL), Preservative-Free, packaged in 10 x 5 mL SiNovember 11, 2019
D-0526-2020Class IIDG Health Acid Reducer Ranitidine Tablets 150 mg, 8-count carton, Distributed by: Dolgencorp LLC 100November 6, 2019
D-0527-2020Class IIAurobindo Ranitidine Caspules 150 mg, 60-count bottle, Rx Only Distributed by: Aurobindo Pharma USA,November 6, 2019
D-0529-2020Class IIRanitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg/5mL) 474 mL bottle, Rx only DistriNovember 6, 2019