Food, drugs, devices › Apollo Care, LLC
Drug recall: PHENYLephrine HCl Injection, 1 mg per 10 mL (100 mcg/mL), Single-Use Syringe, Solution for IV Use Only. Apollo Care, LLC
FDA enforcement event 92348 is a drug recall by Apollo Care, LLC of Columbia, MO, initiated 2 May 2023 and classified Class II, with 16 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 59% of the 281 drug enforcement events initiated in 2023 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Apollo Care, LLC has 3 enforcement events on this register, with a median of 11 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Apollo Care, LLC, Columbia, MO.
Reason for recall
"Lack of Assurance of Sterility"
Distribution
"Missouri only"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0632-2023 | 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 | 2265 syringes | Class II | Ongoing | 24 May 2023 |
| D-0633-2023 | 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 | 90 syringes | Class II | Ongoing | 24 May 2023 |
| D-0634-2023 | 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 | 790 syringes | Class II | Ongoing | 24 May 2023 |
| D-0635-2023 | 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 | 2040 syringes | Class II | Ongoing | 24 May 2023 |
| D-0636-2023 | 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 | 2040 bags | Class II | Ongoing | 24 May 2023 |
| D-0637-2023 | 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 | 1617 bags | Class II | Ongoing | 24 May 2023 |
| D-0638-2023 | 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 | 1113 bags | Class II | Ongoing | 24 May 2023 |
| D-0639-2023 | 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 | 1113 bags | Class II | Ongoing | 24 May 2023 |
| D-0640-2023 | 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 | 1622 bags | Class II | Ongoing | 24 May 2023 |
| D-0641-2023 | 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 | 240 bags | Class II | Ongoing | 24 May 2023 |
| D-0642-2023 | 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 | 413 bags | Class II | Ongoing | 24 May 2023 |
| D-0643-2023 | 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 | 54 bags | Class II | Ongoing | 24 May 2023 |
| D-0644-2023 | 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 | 682 bags | Class II | Ongoing | 24 May 2023 |
| D-0645-2023 | 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 | 491 bags | Class II | Ongoing | 24 May 2023 |
| D-0646-2023 | 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 | 308 bags | Class II | Ongoing | 24 May 2023 |
| D-0647-2023 | 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 | 646 bags | Class II | Ongoing | 24 May 2023 |
Context
Other enforcement events for Apollo Care, LLC
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 29 Jul 2026 | SEMAGLUTIDE 12.5MG (2.5MG/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 | Drug | Class II | 11 |
| 15 Apr 2025 | FentaNYL 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (0.1%) added to 250 mL, 0.9% Sodium Chloride Injection (For Epidural | Drug | Class II | 1 |
All 3 events for Apollo Care, LLC
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Lack of Assurance of Sterility"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Missouri only"
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.