Apollo Care

FDA Regulatory Profile

Summary

Total Recalls
23
510(k) Clearances
0
Inspections
4
Compliance Actions
2

Recent Recalls

NumberClassProductDate
D-0409-2025Class IIFentaNYL 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (0.1%) added to 250 mL, 0.9% Sodium Chloride InjApril 15, 2025
D-0640-2023Class IIVANComycin 1 g added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 MoMay 2, 2023
D-0641-2023Class IIVANComycin 1.75 g added to 500 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801May 2, 2023
D-0645-2023Class IIVANComycin 750mg added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 May 2, 2023
D-0632-2023Class IIPHENYLephrine HCl Injection, 1 mg per 10 mL (100 mcg/mL), Single-Use Syringe, Solution for IV Use OnMay 2, 2023
D-0638-2023Class IIVANComycin 1.25g added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 May 2, 2023
D-0644-2023Class IINorepinephrine 4 mg added to 250 mL of 5% Dextrose Injection, Rx Only, Apollo Care, LLC, 3801 MojaveMay 2, 2023
D-0643-2023Class IIVANComycin 2.5 g added to 500 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 May 2, 2023
D-0637-2023Class IINorepinephrine 8 mg added to 250 mL 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 May 2, 2023
D-0633-2023Class IISuccinylcholine Cl Injection, 100 mg per 5 mL (20 mg/mL), Single-Use Syringe, Rx only, Apollo Care, May 2, 2023
D-0635-2023Class IIKetamine Injection, 50 mg per 5 mL (10 mg/mL), Single-Use Syringe, Rx only, Apollo Care, LLC, 3801 MMay 2, 2023
D-0636-2023Class IIVANComycin 1.5g added to 500 mL of 0.9% Sodium Chloride Injection, Rx only, Apollo Care, LLC, 3801 MMay 2, 2023
D-0639-2023Class IIVANComycin 1.25g added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 May 2, 2023
D-0642-2023Class IIVANComycin 2g added to 500 mL of 0.9% Sodium Chloride Injection, Rx Only. Apollo Care, LLC, 3801 MoMay 2, 2023
D-0646-2023Class IIFentaNYL 500 mcg (2mcg/mL) and Ropivacaine HCL 250 mg (0.1%) added to 250 mL 0.9% Sodium Chloride InMay 2, 2023
D-0634-2023Class IIFentaNYL 50 mcg/mL (2,500mcg Total Dose), 50 mL Syringe, Rx Only, Apollo Care, LLC, 3801 Mojave Ct.,May 2, 2023
D-0647-2023Class IIVANComycin 1.5g added to 250 mL of 0.9% Sodium Chloride Injection, Rx only, Apollo Care, LLC, 3801 MMay 2, 2023
D-0487-2023Class IIFentanyl 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (1mg/mL) added to 250mL 0.9% Sodium Chloride, FoFebruary 8, 2023
D-0277-2022Class IIVANComycin 1g added to 250mL of 0.9% Sodium Chloride (Injection for Intravenous Use Only), 260 mL peOctober 28, 2021
D-0615-2018Class IIVancomycin 1.25g added to 250 mL of 0.9% Sodium Chloride IV bag, Rx only, APOLLOcare, 3801 Mojave CtMarch 7, 2018