The Recall Desk

FDA (Drugs) recall action 92348

Apollo Care, LLC recalled 16 products on 2023-05-24

The FDA (Drugs) publishes a recall like this one as 16 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 16 pages.

Products
16
Announced
2023-05-24
Critical
0
Units
15,524

Why these products were recalled

Lack of Assurance of Sterility

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–16 of 16

  • HighFDA (Drugs)··2023-05-24

    PHENYLephrine HCl Injection Recalled for Lack of Sterility Assurance

    Apollo Care, LLC is recalling 2,265 syringes of PHENYLephrine HCl Injection (100 mcg/mL) due to lack of assurance of sterility. The affected lots were distributed in Missouri only.

    Product
    PHENYLephrine HCl Injection, 1 mg per 10 mL (100 mcg/mL), Single-Use Syringe, Solution for IV Use Only. Apollo Care, LLC, 3801 Mojae Ct., Suite 101, Columbia, MO 65202. NDC: 71170-010-10
    Category
    Distribution
    1 state
  • HighFDA (Drugs)··2023-05-24

    Vancomycin Injectable Drug Recalled Due to Lack of Sterility Assurance

    Apollo Care, LLC is recalling 1,113 bags of Vancomycin 1.25g injection in 250 mL of 0.9% Sodium Chloride solution due to lack of assurance of sterility. The recall affects product distributed in Missouri.

    Product
    VANComycin 1.25g added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-284-25
    Category
    Distribution
    1 state
  • HighFDA (Drugs)··2023-05-24

    Vancomycin injection recalled for lack of sterility assurance

    Vancomycin 1.5g in 0.9% saline solution being recalled due to lack of assurance of sterility. Product distributed in Missouri with lot numbers AC-016629 and AC-016646.

    Product
    VANComycin 1.5g added to 500 mL of 0.9% Sodium Chloride Injection, Rx only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-185-50
    Category
    Distribution
    1 state
  • HighFDA (Drugs)··2023-05-24

    FDA Recalls Fentanyl and Ropivacaine Injectable for Lack of Sterility Assurance

    Apollo Care, LLC recalled 308 bags of fentanyl and ropivacaine injectable solution due to lack of assurance of sterility. The affected product was distributed in Missouri only.

    Product
    FentaNYL 500 mcg (2mcg/mL) and Ropivacaine HCL 250 mg (0.1%) added to 250 mL 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-950-25
    Category
    Distribution
    1 state
  • HighFDA (Drugs)··2023-05-24

    Apollo Care Ketamine Injection Recalled Due to Sterility Assurance Defect

    Apollo Care is recalling Ketamine Injection single-use syringes (2,040 units) distributed in Missouri due to lack of assurance of sterility. Patients should consult their healthcare provider if affected.

    Product
    Ketamine Injection, 50 mg per 5 mL (10 mg/mL), Single-Use Syringe, Rx only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-050-05
    Category
    Distribution
    1 state
  • ModerateFDA (Drugs)··2023-05-24

    Vancomycin IV Injection Recalled for Lack of Sterility Assurance

    Apollo Care LLC is recalling VANComycin 1.5g IV injections because the manufacturer could not provide adequate assurance that batches met sterility standards. The recall affects 646 bags distributed in Missouri.

    Product
    VANComycin 1.5g added to 250 mL of 0.9% Sodium Chloride Injection, Rx only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-184-25
    Category
    Distribution
    1 state
  • HighFDA (Drugs)··2023-05-24

    Norepinephrine injectable recalled for lack of sterility assurance

    Apollo Care is recalling Norepinephrine 4 mg dextrose injection (682 bags) due to lack of assurance of sterility. Distribution was limited to Missouri.

    Product
    Norepinephrine 4 mg added to 250 mL of 5% Dextrose Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-500-25
    Category
    Distribution
    1 state
  • HighFDA (Drugs)··2023-05-24

    Injectable Vancomycin Recalled Due to Lack of Sterility Assurance

    Apollo Care LLC is recalling 1,113 bags of VANComycin injectable solution due to lack of assurance of sterility. The recalled product was distributed in Missouri.

    Product
    VANComycin 1.25g added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-264-25
    Category
    Distribution
    1 state
  • HighFDA (Drugs)··2023-05-24

    FDA Recall: VANComycin 750mg Injectable Lacks Sterility Assurance

    Apollo Care's VANComycin 750mg injectable lacks assurance of sterility. The 491 bags distributed in Missouri are being recalled due to potential contamination risk.

    Product
    VANComycin 750mg added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-255-25
    Category
    Distribution
    1 state
  • HighFDA (Drugs)··2023-05-24

    Vancomycin Injectable Drug Recalled Due to Lack of Sterility Assurance

    Apollo Care, LLC is recalling VANComycin 1 g added to 250 mL of 0.9% Sodium Chloride Injection due to lack of assurance of sterility. The recall affects 1,622 bags distributed in Missouri.

    Product
    VANComycin 1 g added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-254-25
    Category
    Distribution
    1 state
  • HighFDA (Drugs)··2023-05-24

    Vancomycin Injectable Antibiotic Recalled Due to Sterility Concerns

    Apollo Care, LLC is recalling VANComycin 1.75 g injectable solution (NDC 71170-194-50) due to lack of assurance of sterility. The recall affects 240 bags distributed in Missouri.

    Product
    VANComycin 1.75 g added to 500 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-194-50
    Category
    Distribution
    1 state
  • HighFDA (Drugs)··2023-05-24

    Succinylcholine Injection recalled for lack of sterility assurance

    Apollo Care, LLC is recalling Succinylcholine Cl Injection due to lack of sterility assurance. The affected lot was distributed in Missouri.

    Product
    Succinylcholine Cl Injection, 100 mg per 5 mL (20 mg/mL), Single-Use Syringe, Rx only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-020-05
    Category
    Distribution
    1 state
  • HighFDA (Drugs)··2023-05-24

    FDA Recalls Apollo Care Norepinephrine Injections Due to Sterility Assurance Failure

    Apollo Care, LLC is recalling 1,617 bags of Norepinephrine 8 mg intravenous injection distributed in Missouri due to lack of assurance that the product meets sterility requirements.

    Product
    Norepinephrine 8 mg added to 250 mL 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-550-25
    Category
    Distribution
    1 state
  • HighFDA (Drugs)··2023-05-24

    Vancomycin Injectable Solution Recalled Due to Lack of Sterility Assurance

    Apollo Care, LLC is recalling 413 bags of Vancomycin 2g injectable solution (Lot #AC-016638, expiration 05/27/2023) distributed in Missouri due to lack of assurance of sterility.

    Product
    VANComycin 2g added to 500 mL of 0.9% Sodium Chloride Injection, Rx Only. Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-204-50
    Category
    Distribution
    1 state
  • HighFDA (Drugs)··2023-05-24

    Fentanyl Injectable Syringes Recalled for Lack of Sterility Assurance

    Apollo Care's fentanyl 50 mcg/mL injectable syringes are recalled due to lack of assurance of sterility. The 790-syringe batch distributed in Missouri may pose contamination risks if administered.

    Product
    FentaNYL 50 mcg/mL (2,500mcg Total Dose), 50 mL Syringe, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-910-25
    Category
    Distribution
    1 state
  • HighFDA (Drugs)··2023-05-24

    VANComycin Injectable Recalled for Lack of Sterility Assurance

    Apollo Care, LLC is recalling a VANComycin injectable medication due to lack of assurance of sterility. The affected lot was distributed in Missouri only.

    Product
    VANComycin 2.5 g added to 500 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-224-50
    Category
    Distribution
    1 state